QC Supervisor Resume Samples

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H Schowalter

Harmon

Schowalter

95447 Moore Centers

Phoenix

+1 (555) 983 6520

95447 Moore Centers

Phoenix

Phone

p +1 (555) 983 6520

Experience Experience

Houston, TX

QC Supervisor

Houston, TX

Corwin Group

Houston, TX

QC Supervisor

Organize the Quality Control staff and workload to meet or exceed departmental performance standards and achieve business key performance indicators
Develop and maintain visual management indicators to monitor key metrics to include dwell time (cycle time)
Assist QC Management Team with customer and FDA audits, and follow-up with responses to observations
Resolving personnel issues and work place conflicts Troubleshooting, problem solving operational and or performance issues
Perform other duties as requested by managers to support Quality activities
Drive process improvements, quality system improvements, as well as cultural change
Develop and analyze quality trend data and manage development of specifications, and establish optimal quality levels

Boston, MA

Site QC Supervisor

Boston, MA

Champlin and Sons

Boston, MA

Site QC Supervisor

Establishes implements and maintains site quality program. Coordinates with engineers, suppliers, subcontractors, regulatory representatives and field to ensure that work is done correctly the first time
Surveillance/Audits of site Contractor Quality Control Programs
Responsible for all aspects of welder qualification on-site testing
Responsible for issuance, control and coordination of Post Weld Heat Treatment (PWHT) and Non Destructive Examination (NDE) contacts
Establishes inspection plan and track inspections/actions identified
Approves site testing such as soils testing, concrete placement and grout breaks, hydro tests, and NDE testing and verify tests are properly documented
Reviews and control documentation for the certification of construction equipment and testing equipment

present

Dallas, TX

QC Supervisor The North Face

Dallas, TX

Russel, Bogisich and Schaden

present

Dallas, TX

QC Supervisor The North Face

present

You organize the day by day running of the Quality Assurance inspection process when stock is received into the warehouse
You note all the discrepancies compared to the specifications on a report sheet
You manage a team of quality auditors: organisation of the workload, follow-up of performance, train and coach
You establish control-related standards and procedures. You keep all related documents and work instructions up to date
You co-operate with the Warranty Department, customer services (whole sale and E-com and D2C) in order to investigate and report back all claims we receive from customers
You train the quality auditors on an on-going basis in all aspects of Quality Assurance
You work with Accounting to implement and work on non-compliance & quality issue charge backs versus Suppliers

Education Education

Bachelor’s Degree in Life Sciences Discipline

Carnegie Mellon University

Bachelor’s Degree in Life Sciences Discipline

Skills Skills

Thorough knowledge of aseptically filled sterile drugs. Additional knowledge of biologically derived products and non-sterile solid doses helpful
Highly flexible and adaptable. Able to work independently in a fast paced multitasking environment
Excellent ability to prioritize work load for group and problem solve. Changes work within their group quickly in unexpected situations
Strong mentor for staff with ability to help others develop and maintain a great team
Strong analytical, problem solving skills and troubleshooting skills including understanding of risk management and risk-based quality systems
Demonstrates detailed expertise in complex functional/technical area or broad breadth of knowledge in multiple areas
Knowledgeable concerning 21CFR, USP, EP, and ICH regulatory guidelines
Strong technical knowledge of environmental monitoring and utilities testing (endotoxin, conductivity, bioburden, nitrates, TOC)
Strong attention to detail
Implement principles of performance evaluation and prediction methods are used to improve product systems safety, reliability, and maintainability

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15 QC Supervisor resume templates

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QC Supervisor EM / Micro Resume Examples & Samples

60%: Supervision of daily and weekly activities of staff and operational oversight of group, data review, scheduling, oversight of group training
20-30%: GMP documentation related activities (ex. SOP revisions, quality systems related events, method related project documents as required), oversight of group metrics
10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
Ability to work around chemicals (if working around the laboratories)
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time

QC Supervisor nd / rd Shift Resume Examples & Samples

Maintains up-to-date knowledge of process improvements and technical developments
Responds to and proactively reduces consumer complaints
Three years prior experience in Quality Control required

QC Supervisor Resume Examples & Samples

Organize the Quality Control staff and workload to meet or exceed departmental performance standards and achieve business key performance indicators
Assist Manufacturing /MPD/QA and QS in carrying out investigation of product failure due to processing and/or material defects
Develop technical staff instructing and demonstrating appropriate technical skills/requirements for general product testing
Carry out all duties according to Standard Operating Procedures, Food and Drug Administration Regulations and Good Manufacturing Practices
Manage team to include interviewing, hiring, performance management, and goal setting. Manage departmental budget
Develop, write and implement all Quality Control procedures
Investigate out of limit test results
Work with Quality Systems to develop testing plans for new devices as requested. Additionally, update or modify existing testing as required
Review Process Variances as directed
Review stability studies
Assure timely review of all finished good devices, DCM and raw component pretests
Review Internal Device failures and initiate root cause counter measures
Report any actual or potential safety hazards to the Supervisor, Human Resources, Safety Specialist or Senior Management. Address and correct safety issues
Participate as a member of the lab safety committee. Ensure that Quality Control lab is compliant with all safety procedures
Utilize continuous improvement and lean tools to optimize the flow of the lab
Develop and maintain visual management indicators to monitor key metrics to include dwell time (cycle time)
Communicate status of critical back order items through daily management
Lead and drive 5S and standard work in the laboratory. Ensure that the laboratory operates in a clean and organized manner
Lead key projects to include integration of new products and processes in the laboratory
Manage personnel and fiscal budgets of the Quality Control department
In addition, other duties may be assigned as the need arises
Bachelors of Science in Medical Technology or related field required
Minimum of 1 year laboratory experience
Prior experience in a management position or leading people preferred
Problem solving and analytical skills a must

QC Supervisor Resume Examples & Samples

US Citizenship is Required
Must have an active Secret security clearance, and maintain eligibility for the duration of the contract
Requires a Bachelor’s degree in a related field - Education may be substituted for years of practical experience within the related field of discipline, two years of experience for every year of education
Five (5) years’ experience in Quality Control and Quality Assurance is required
Must have the ability to collect, analyze and summarize data and to prepare clear and concise reports
Requires experience in effectively dealing with international and headquarters staff, and sensitivity to other cultures
The ability to exercise sound judgment and make decisions independently is required
Must have excellent organizational and time management skills, with the ability to handle multiple tasks and administrative details in a fast paced and constantly changing environment
Department of State or Department of Defense experience is desired
Prefer two (2) years’ of international experience in challenging locations, preferably working in the Middle East, with a working knowledge of customs and cultural differences
Certified Quality Management or Certified Manager or Quality accreditation is desired
Knowledge in the discipline of Live Services Support projects in an international environment is preferred
Advanced computer skills, specifically in Microsoft Word and Excel are required
Must complete and pass a drug screen and complete a favorable physical examination
Requires expert professional, oral and written English communication skills, to present, facilitate and disseminate information
Must be willing and able to perform physical activities including but not limited to heavy lifting and moving of items, parts, assemblies and equipment up to the safety regulation maximum; climbing in and out of equipment; crawling; and working outdoors. This includes being able to lift and carry 40 pounds of personal protective equipment for extended periods of time; and being capable of running and ‘duck & cover’ during emergencies without putting oneself or others at risk
Must be able to work a minimum of 6 days per week and 10 hours per day, some jobs have higher daily and weekly minimums

QC Supervisor Resume Examples & Samples

Supervise and provide day to day direction and support for (three to ten) analysts, potentially across multiple shifts and functions (raw materials, in-process, finished goods, cleaning validations, or “project”). Will be responsible for annual performance reviews, performance feedback, coaching and any formal “personnel” related items
Exhibit analytical mastery across all testing methodologies in the QC laboratory pertaining to pharmaceutical manufacturing and serve as mentors and coaches for individuals within the QC organization. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.). This is achieved by recognition both inside and outside of Quality as a “go to” individual in all areas of testing
Coordinate scheduling of laboratory work and procedures to support manufacturing needs, i.e., raw materials, in-process, finished goods, cleaning validation, in process and stability testing along with management directed work. Effectively communicate work responsibilities and timelines to Associate, QC, and Senior QC Analysts
Effectively motivate analysts and keep work flow on track to meet or exceed customer’s timelines
Supervise multiple shifts of QC, Senior QC, and Principal QC Analysts
Evaluate and implement new analytical technologies, i.e., computer systems, software, HPLC and GC data systems, instrumentation, and updated compendia methodologies, etc
Able to seamlessly move into role of QC Manager on a periodic basis in the absence of formal management staff or as part of a special project
Develop and Supervisor training for QC, Senior, and Principal QC Analysts on test methods and SOPs
Assist QC Management Team with customer and FDA audits, and follow-up with responses to observations
Oversee “out of specification” and aberrant lab investigations
Assist with special administration projects and other tasks as needed
Recommend and change SOPs as required
Update and maintain SOP’s relating to the QC department
Review and sign off on analytical data and Certificates of Analysis
Responsible for ensuring that the laboratory operates in a clean, uncluttered, safe, and efficient manner
Exceptional laboratory knowledge and skill set with a demonstrated ability to understand, perform, and recognize problems with compendia and customer supplied testing methods
Mastery with analytical techniques as pertaining to a pharmaceutical manufacturing setting. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.). This is achieved by recognition both inside and outside of quality assurance as a “go to” individual in all areas of testing
Prior supervisory experience is preferred, but not required given organizational option to “grow” into role
Must be an outstanding communicator, approachable and able to make difficult decisions
Ability to multi-task with high efficiency
Ability to coordinate and guide a group of individuals towards a common goal
Ability to work well under pressure with no supervision or direction and maintain efficiency and meet or exceed customer’s deadlines
Ability to communicate effectively to analysts, management, customers, and regulatory bodies
Interaction with internal and external stakeholders and regulatory bodies will be commonplace
In-depth understanding of cGMP regulations and FDA/USP/EP/BP/ICH/etc. guidelines
General computer literacy including use of Microsoft Word and Excel
Ability to coordinate and prioritize to support manufacturing and quality agreements
Excellent working knowledge of all SOP’s related to the QC function as well as general safety procedures associated with QC laboratory and pharmaceutical industry
Ability to read and understand MSDS requirements and restrictions
Experience in the pharmaceutical manufacturing industry preferred

QC Supervisor The North Face Resume Examples & Samples

You organize the day by day running of the Quality Assurance inspection process when stock is received into the warehouse
You note all the discrepancies compared to the specifications on a report sheet
You manage a team of quality auditors: organisation of the workload, follow-up of performance, train and coach
You establish control-related standards and procedures. You keep all related documents and work instructions up to date
Occasionally you attend Supervisor meetings in the DC to remain connected with all DC related processes and activities
You train the quality auditors on an on-going basis in all aspects of Quality Assurance
You report regularly back (with daily and monthly reports) into the Quality Assurance/Quality Control Managers and product teams worldwide to work on flaws in design or improvements in manufacturing processes to better control Quality Control or costs. You report on a seasonal basis about the Suppliers’ performance with case history and pictures
You co-operate with the Warranty Department, customer services (whole sale and E-com and D2C) in order to investigate and report back all claims we receive from customers
If required, assist in seasonal Sample review with TNF product development team
You work with Accounting to implement and work on non-compliance & quality issue charge backs versus Suppliers
You visit production locations in Europe and in the Mediterranean countries if required, to conduct Quality Control checks during production cycles to ensure that A grade goods get delivered to the DC

QC Supervisor Resume Examples & Samples

A bachelor degree (preferably in chemical/process engineering or food technology) would be required to adequately understand the processes and terminology involved in the Quality Control role
Highly developed time management and communication skills
Experience with HACCP, sanitation, allergen control, GMP and other quality programs
Advance Sensory in flavors ingredients
Min 5 years food industry experience, with at least 2 years in QC supervision roles, with demonstrated success in developing and/or working within a HACCP based QC system

QC Supervisor Resume Examples & Samples

Supervise operations of the QC Direct Materials Laboratory testing of chemical and component raw materials
Manage operations in a network environment as required by Roche-Genentech integration activities accounting for end-to-end business process considerations including departmental capacity, process capabilities, forecast analysis and customer requirements
Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines
Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities
Assign activities to staff
Routinely monitor progress and completion of assigned staff activities
Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions
Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies
Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including, but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds
Meets scheduled performance of 95% on time
Perform other duties as requested by managers to support Quality activities
Proven verbal and written communication skills, ability to organize and present information both formally and informally
Flexibility in problem solving providing direction and work hours to meet business objectives
Ability to make sound decisions about scheduling, allocation of resources, and managing priorities

QC Supervisor Resume Examples & Samples

Bachelor's degree in Science or Engineering
Experience in Quality System in Medical Devices manufacturing
Knowledgable in ISO13485, MDD, PAL Japan, QSR and other international standards
Possesses good interpersonal, analytical and problem solving skills
Able to communicate in English language

QC Supervisor Resume Examples & Samples

Responsibility for product and process support
Drive process improvements, quality system improvements, as well as cultural change
Develop and analyze quality trend data and manage development of specifications, and establish optimal quality levels
Ensure conformance of ISO 13485:2003, ISO 14971, the Medical Device Directive (93/42/EEC), U.S. Food and Drug Administration’s Good Manufacturing Practice for Medical Devices (21 CFR 820), and CMDR
Responsible for detecting, identifying, correcting and preventing re-occurrence of problems within the quality system
Maintain Dock to Stock Program
To aid in the development of product test procedures and evaluation for release
To provide support and initiative in the documentation, development, and release of new product, and new versions of products

QC Supervisor Resume Examples & Samples

Scheduling and Planning of routine testing for the Electrophoresis team. Ensures equipment and the work area is safe for employees to perform their duties
Ensures team members are adequately trained for execution and review of assays
Assay/Documentation/Quality System Review
Attending department related meetings
Independently drive projects to on-time completion
Resolving personnel issues and work place conflicts Troubleshooting, problem solving operational and or performance issues
Other – such as leading OE initiatives, Improvements, Helping with Transfers, hiring of staff
Outstanding ability to speak publicly. Displays a calm and controlled demeanor in all situations
Outstanding ability to interpret data and troubleshoot assays in area of expertise
Perform assigned, complex and/or varied tasks
Excellent ability to prioritize work load for group and problem solve. Changes work within their group quickly in unexpected situations
Clearly outlines and gives instructions to analysts in their team
Direct, control and plan tasks/projects
Brainstorming
Excellent ability to communicate in both written and verbal format. Is able to clearly communicate via email or memo as required

QC Supervisor Resume Examples & Samples

Supervise laboratory investigations for EM and utilities. Train analysts in the investigation process. Write or review investigation reports as required by the investigation procedure
Maintain aseptic gowning qualification and perform environmental monitoring for each aseptic fill line when reports are between shifts and when reports are absent
Work with manufacturing to appropriately schedule direct reports work. Scheduling coordination with weekday first shift and off shift supervision will be required as well
Ensure all assigned timelines are met including reviewing, deviations, projects, weekly assignments etc
Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedures and assist in the preparation of training programs and curricula
Provides personnel to support the training of manufacturing personnel on MODA, water sampling, settle plates, RODAC, and air plates
Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff
Write, revise, or review SOP’s, environmental and validation protocols, and controlled forms
Identify and report unsafe conditions within the laboratory
Actively participate and contribute to the Laboratories mission and objectives. Facilitates dialogue and values input from others
Deliver key business messages in a timely manner and support continuous improvement
Supportive/Proactive approach to business demands
Strong technical knowledge of environmental monitoring and utilities testing (endotoxin, conductivity, bioburden, nitrates, TOC)
Thorough knowledge of aseptically filled sterile drugs. Additional knowledge of biologically derived products and non-sterile solid doses helpful
Strong mentor for staff with ability to help others develop and maintain a great team
Excellent organizational, planning, and scheduling skills
Ability to make decisions efficiently and correctly to align with GMP or SOP requirements
Maintains a clean, organized lab environment
Ability to cope with a rapidly changing work environment
Motivates personnel to participate and grow within the department

QC Supervisor Resume Examples & Samples

Plan and deploy drivers’ quality and performance
Assure SOPs implementation
Solving specific cases
Daily, Weekly Report about plan Audit & Control drivers’s quality
Understand about product deeply
Understand operating process and behavior of drivers, Passengers
Planning skill
Communication and Problem Solving Skill
Analyzing and Auditing
Office
Work on own initiative and as part of a team, numaracy

QC Supervisor Resume Examples & Samples

Perform all Marina Services Worker duties
Assist in holding the pre-shift meetings to ensure that the Boat Rentals dock team are aware of the day’s tasks, reservations, visiting VIPs, FOCUS & Safety of the day and any other miscellaneous information to ensure successful operations
QC Supervisor should be highly knowledgeable about Lake Powell Resort and Marinas and the surrounding areas; acting as a concierge resource for all guests. This includes but is not limited to: retail, boat rentals, food & beverage opening hours and services, tours and activities and surrounding area amenities and activities such as other National Parks in The Grand Circle
Train Marina Services Workers on all aspects of the role; in order to develop a team of customer service focused professionals
Respond directly to all customer complaints and ensure they are resolved efficiently and immediately in a professional manner which does not negatively impact on the reputation of Lake Powell Resorts and Marinas
QC Supervisor may be required to coordinate, correct, track and submit payroll for the Boat Rental department; ensuring accuracy, proper transfer of labor and timely weekly reporting
QC Supervisor may be required to complete monthly safety inspections, complete electrical readings and file incident and injury reports on an ongoing basis
QC Supervisor is required to assist management in scheduling all Boat Rentals employees in accordance with labor budgets and assigning work tasks to the Marina Services Workers
QC Supervisor will ensure everything operates smoothly in manager’s absence and that all customer relations issues are handled effectively
Must ensure cleanliness and a pleasant atmosphere throughout The Boat Rentals dock at all times
Verify all work stations are secure and clean at close of shift
Must be computer literate in Microsoft Office
May be required to drive company ATV/Cart, boats, and/or vehicles

QC Supervisor Resume Examples & Samples

Aid in the preparation of monthly and quarterly reports for in-process data, review and analysis of testing trends and Microbial Identifications. Efforts include the resolution of MODA/LIMS discrepancies and approval of MODA/LIMS entries
Supervise, train, and provide leadership and technical expertise for the staff
Evaluate the accuracy of data and trend results
Perform routine and non-routine studies
Assist in the development of procedures and troubleshoot assays
Assist in the supervision of personnel, scheduling and daily operations of the laboratory
Maintain and control laboratory inventories
Validate methods and laboratory equipment and write procedures
Provide for the safety of the employees
Provide laboratory support for inspection readiness
Work with Project Teams to drive timelines and efforts to the common goal
Knowledgeable concerning 21CFR, USP, EP, and ICH regulatory guidelines
Experience in quality control practices and knowledge of cGMP required
Fill/Finish experience a plus
Accomplish most tasks with minimal supervision
Demonstrates good interpersonal skills and leadership qualities
Experience in microbiology and aseptic techniques required
Experience with Microsoft Word, Excel, PowerPoint and Access are necessary
Proficient in written and verbal communication skills

QC Supervisor Resume Examples & Samples

Consults with laboratory management regarding priority of data and reports submitted to QC and assigns work accordingly. Supervises QC staff to include scheduling, procedural interpretation and performance evaluation
Trains new QC Reviewers and laboratory staff
Evaluates lab data for compliance with methods, SOPs, quality and project timelines. Serves as primary contact for the laboratory unit regarding compliance issues
Consults with QC staff and laboratory staff to mediate disagreements that may arise. Monitors consistency in interpretation of procedural requirements and content of QC reports
Evaluates findings produced by QC staff and determines appropriate action
Identifies issues that may require follow-up inspection. Reports findings to laboratory staff and management
Participates in client and regulatory inspections providing information regarding the QC program. Facilitates responses from the lab and retrieval of data
Knowledge of SOPs and Federal Regulations to include GLP and GMP
Knowledge of analytical methodologies, instrumentation and method validation
Thorough knowledge of chromatography and divisional SOPs
Ability to deal with multiple and changing priorities
Leadership and time management skills
Ability to train and mentor staff

QC Supervisor Resume Examples & Samples

Supervises second shift Quality Control operations
Works with other department heads to ensure the highest standard of quality for products as specified by Sanderson Farms’ quality assurance program
Cooperates with customer representatives to ensure that current specifications for products are being met
Works with USDA inspection and grading personnel and production supervisors to ensure all requirements are being met
Informs Quality Control Superintendent and Division Manager on variances from standards of equipment, personnel, incoming materials and finished products as it relates to quality control
Trains and supervises activities of quality control personnel in the following areas at the Processing Division: poultry slaughter, eviscerating and chilling; fast food cut-up; marination; chill pack; deboning; other operations as needed
Ensures quality of products received and produced by daily machine checks, moisture tests, temperature checks, saw cut checks, grade checks, proper icing, etc
Ensures high yields by checking the accuracy of scales, scale sheets, weights from previous day’s production, package weights, etc.; monitor plant for floor waste, and do drain checks for usable product
Prepares and distributes daily quality control reports for management
Monitors plant for compliance with USDA regulations
Manages the SIS program in plant
Investigates and responds to customer inquiries and complaints as directed by the Division Manager, and Quality Control Superintendent
Maintains quality control hold tag log and supervises hold tag program on second shift
Inspects facility for pest activity and works with pest control company on extermination
Monitors, evaluates and coordinates with sales and plant management, products returned from customers
Communicates useful information to plant supervisors
Orders necessary supplies and charts and coordinates with Division Manager and Quality Control Superintendent in preparing the quality control budgets
Provides leadership and encouragement in a mood of safety consciousness as well as efficiency of production

QC Supervisor Bioanalytics Laboratory Resume Examples & Samples

Supervision of laboratory personnel and adjustment of schedules to maximise efficiencies and adequately support on time batch/reagent testing and release, analytical method transfer and other departments
Compliance with Standard Operating Procedures and Registered Specifications
Conducting non-conformance investigations and identifying laboratory practices and procedures for further development / improvement
Awareness of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and analytical methods
Approval of SOPs, trend data, investigations, non-conformances, validation/transfer protocols, reports, and equipment qualifications
Participation in regulatory agency inspections
Conducting performance appraisal reviews for laboratory direct reports
Monitoring and assisting staff with work progress
Five years of experience in a pharmaceutical laboratory or related technical function with at least one year of supervisory experience
Strong background in cell based Bioassays and aseptic technique is required. Experience in ELISA and SPR (Biacore) would also be an advantage
Excellent written and verbal communication skills and experience of working with teams and influencing decisions

QC Supervisor Resume Examples & Samples

Oversees and directs the work of Quality Control Chemist who perform testing of raw materials, intermediates, and APIs in support of process development and manufacturing
Conducts QC testing as required
Interact with Plant Manager to assess Quality Control support needs and coordinates coverage for all shifts, assigns projects/ responsibilities, delegates analyses (as needed), reviews data
Supervises of QC personnel (including hiring decisions, evaluations of performance, and identification of training and development needs)
Participates in deviation and OOS investigations
Develops, improves, and revises SOPs, test methods, and other GMP documentation as needed
Assures compliance of laboratory operations and contributes to laboratory organization including calibration, qualification and re-qualification of instruments
Leads the transfer of analytical procedures from the Analytical Development group as well as directly from the client sites
Identifies and leads continuous improvement initiatives
Actively participates in quality and safety audits and walkthroughs
Directs and advises the Quality Control group to achieve long and short term goals and objectives
Provides guidance and direction to other Johnson Matthey Pharma Services (JMPS) staff in order to implement the quality vision for both JMPS sites
Provides support to Devens, MA location as needed or directed by the manager
Manages staff in full compliance with cGMP requirements
Responsible for departmental audit readiness and for participating in quality audits with FDA and customers
Ensures staff acts in accordance with Johnson Matthey quality policies and practices with respect to cGMP and other related requirements
Manages compliance with state and federal regulations, including but not limited to GMP, DEA, and FDA
Implements and applies cGMP concepts in association with department specific responsibilities
Demonstrates technical expertise and self-assuredness in applying cGMP standards
Manages staff in full compliance with all appropriate EH&S policies and procedures
Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers
Ensures staff acts in accordance with EH&S policies, practices and procedures
Addresses staff issues accordingly if there are EH&S violations
Actively participates in root cause investigations on near misses and all incidents.Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department
Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc
Implements, applies and places emphasis on EH&S concepts with department specific responsibilities
Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures
Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities

QC Supervisor Resume Examples & Samples

Responsibilities may include for the daily scheduling of analyst in one of the HPLC/Raw/Physical testing groups on various tasks and instrumentation
Give continued support in an effort to maintain laboratory output to meet specified deadlines/objective/metric expectations
Develops, coaches and mentors direct reports
Verify that laboratory worked performed is in accordance with FDA requirements and cGMP standards
Review and approve laboratory reports
Establish, implement and complete training of lab personnel in the QC group
Assists in routine administrative duties
Write, revise or approve new/revised SOP and AN procedures
Write KLE, LIR, and OOE investigations
Prepare and review validation protocols and reports; equipment calibration reports/documentation
Perform and track area team meetings; general laboratory meetings
Assist with performing mid/annual performance reviews and set objectives
Assist with internal and external quality laboratory audit endeavors
Attend meetings and provide status update on projects, various testing, production and planning schedules
Participates and supports Operational and Laboratory Excellence initiatives
Assists/supports in reviewing test data, reports and procedures to determine compliance with cGMP and SOP requirements
Support and promote the Company Standards of Ethics & Conduct is an essential element of the performance standards and will be used in the overall performance ratings

QC Supervisor Resume Examples & Samples

Reviews quality reports
Provides immediate supervision to inspectors, checking work at frequent intervals
Demonstrates expert functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills
understands the strategic impact of the function across sites
Ability to define problems, collect data, establish facts and draw valid conclusions

QC Supervisor Resume Examples & Samples

Supervise operations of the QC Microbiology Laboratory and create and update team schedule
Document laboratory deviations, laboratory errors, OOS investigations and OOT investigations
Propose effective CAPAs for investigations and deviations
Oversee and review release testing for in-process and finished products for compliance with cGMPs
Oversee and review stability testing for compliance with cGMPs
Ensure cGMP compliance of all activities performed
Represent QC Microbiology in internal and external audits as required
Oversee and schedule activities related to validation of lab equipment and assays
Author and review of technical reports
Review standard operating procedures
Coordinate implementation of new methods
Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines
Provide leadership and guidance to team to ensure successful completion of laboratory projects and the release of product with strict adherence to cGMPs
Bachelor’s degree in Life Sciences discipline and 6 years experience in cGMP lab environment
PREFERRED QUALIFICATIONS
Experience facilitating meetings
Experience in a lead or Supervisory, specifically training, coaching and mentoring junior level employees
Experience in managing direct reports
Familiarity with Deviation Management Systems (i.e. Trackwise)
Subject matter expert in one laboratory methodology (i.e., Bioburden/LAL/TOC/ELISA)

QC Supervisor Resume Examples & Samples

Direct and coordinate the activities of quality employees engaged in the inspection of raw materials, in process materials and finished goods. -- 20 %
Assist with company's deviation and nonconforming material processes. Initiate and/or review documentation related to these processes as well as performing risk assessments. Participate in out-of-specification and failure investigations and recommend corrective actions. -- 15%
Assist with the routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols. Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release. -- 10%
Confer with other supervisors to coordinate operations and activities within or between departments. Serve as a technical liaison between quality control and other departments, vendors, or contractors. - 15%
Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Develop or update procedures, policies, or standards. Write and review SOP's, batch production records, quality records, and general documentation. Research, compile, and prepare reports, manuals, correspondence, or other information required by management or governmental agencies. -- 20%
Identify quality problems and recommend solutions. Assist in troubleshooting any quality concerns in manufacturing. -- 15%
Will assist Quality Department interfacing with FDA, ISO registrar, vendors, suppliers, and customers as it relates to Good Manufacturing Practices including responding with corrective/preventive actions when non-conformances are found. -- 5 %
1 - 2 years of experience in a quality specialist / quality engineering role
2 - 4 years of experience in the Medical Drug / Device Industry
Working knowledge of quality systems and regulatory requirements (ISO 13485, 21 CRF Part 210/211 and QSR part 820)
Strong analytical, problem solving skills and troubleshooting skills including understanding of risk management and risk-based quality systems
Experienced in technical writing in an FDA regulated industry
Strong people management, coaching, and development skills
Proficient computer skills (MS Windows, MS Office applications)
Strong interpersonal skills -- a proven team player who contributes to a results focused and motivating team environment
Highly flexible and adaptable. Able to work independently in a fast paced multitasking environment
Strong risk analysis skills

QC Supervisor Resume Examples & Samples

Use of Microsoft Suites (Word, Excel, Powerpoint)
Use of Laboratory computer systems
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Use of HPLC's, A280, Waters and Agilent systems, micro assays such as TOC's and endotoxins
Outstanding ability to speak publicly. Maintains control of meetings

QC Supervisor Separations Laboratory Resume Examples & Samples

Responsibility for finished product and drug substance release testing and laboratory documentation
Supervision of laboratory personnel and adjustments to schedules to maximise efficiencies and adequately support production and other departments
Issue trend reports on investigations, non-conformances and environmental monitoring and identify laboratory practices and procedures for further development/improvement
Maintain within the QC Separations laboratory, current corporate and industry requirements and compliance trends as they pertain to laboratory operations
Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
Participate in regulatory agency inspections as required
Conduct performance appraisal reviews for laboratory direct reports
Monitor and assist staff with work progress
A minimum of a third level qualification (Degree) in Biochemistry or related discipline
5 years of experience in a pharmaceutical / healthcare laboratory or related technical function with at least a year of supervisory experience
Strong background in chromatography and aseptic manufacturing is required
The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline
The successful candidate must demonstrate an ability to work independently in assay and recognize anomalous trends or results
The successful candidate must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines
Excellent communication and the ability to work in a team based collaborative environment are required

QC Supervisor Resume Examples & Samples

Previous Experience working in a meat processing facility is desired
Ability to work in cold/hot environments and on weekends as necessary
Pork product specification knowledge
Strong computer Skills required
High School degree or equivalent required, or equivalent combination of education and experience
Bachelor’s Degree in applicable field preferred
Work with operations team to ensure that product is being produced to specification
Work with area superintendent and USDA to ensure that processes comply with plant HAACP plans
Train and mentor employees for program compliance
Review and monitor customer claims on product quality to continually improve processes
Lead a team of approximately 20 QA Techs and Graders
Ensure plant employees are following GMP's

QC Supervisor Resume Examples & Samples

Supervise the sampling and inspection of incoming VSB finished products including timely disposition, proper retention of samples and documentation of Product Evaluation records
Work with Contract Manufacturers in timely resolution of quality related issues observed during Finished Product Inspection process
Track and report product quality issues for Vendor Scorecard Program
Conduct and author Material Review and make disposition decisions
Manage Market Withdrawal/Recall operations and ensure timely close out of Market Withdrawal/Recall including processing of returns, tracking of and following up on store and DC responses, and returning to vendor/disposing of affected product
Oversee the quarantine process
Maintain proper documentation of Finished Product Inspection, Market Withdrawal/Product Recall records
Author and implement all required SOPs related to Finished Product Inspection and Market Withdrawal/Recall
Report monthly metrics relative to Finished Product Evaluation, Market Withdrawal/Recalls, and Quarantine process
Read, understand and apply current Good Manufacturing Practice (cGMP) regulation, requirements, and company policies in performing duties
Receive annual cGMP training
5+ years of quality control experience

QC Supervisor Resume Examples & Samples

Lead identification, development and implementation of best practice techniques, including emerging technologies and concepts. Identify and implement process improvements
Align strategies with Company strategies and objectives
Provide internal leadership, training and day-to-day direction of peers and subordinates
Plan, organize, communicate and monitor department resources to achieve effective utilization of employees, with safety, regulatory, quality, productivity and financial requirements. Provide technical guidance
Determine task performance/skill requirements. Evaluate employee skill levels, focus training plans on deficiencies, and reinforce employee development and training
Keep employees informed of area, business, and policy changes. Communicate goals and current level of group and individual performance
Retain sufficient expertise to evaluate personnel and monitor department performance
Lead, direct and plan daily inspection activities
Forecast and plan for future resource needs
Track, manage and procure calibration of measuring and test equipment for shop equipment
Oversee inspection process for effective implementation at both Shoreview and NuCrane
Be issue owner of inspection CAPALs and drive to effective, timely closure
Support inspection activities conducted at suppliers
Off-shift/weekend support required when business needs dictate
Create, maintain and report non-conformance metrics
4+ years of quality experience

QC Supervisor Resume Examples & Samples

Supervise and motivate the Incoming Quality Inspection team and mitigating conflict to maintain a high level of moral as needed
Lead direct engagement of the team through cross training processes for individual development
Set and uphold performance objectives to ensure development and growth of the team. This includes writing and presenting annual reviews as well as tracking individual performance on a reoccurring basis
Ensure the IQC inspector team performs at an effective and efficient level while promoting a continuous improvement environment
Lead IQC lean initiatives and encourage/promote the team to continuous improve internal processes as well as process that interact with adjacent departments (receiving/warehouse)
Responsible for meeting IQC productivity and efficiency metrics, as well as aggressively targeting metric improvement
Support the CAPA/NC system as it pertains to overall IQC quality and ownership/leadership when directly involving incoming quality
Knowledgeable in applicable domestic and international regulations and standards for incoming inspection (QSR, MDD, 13485, etc)
Performs other duties as assigned by manager
Innovate measurement techniques for more efficient and consistent accuracy between operators
Knowledgeable to internal Quality Inspection procedures as well as print/inspection standard interpretation
Ability to navigate through Agile PLM to process Engineering Change Requests, Engineering Change Orders as well as Manufacturing Change Orders in a timely and efficient manner. Changes include and not limited to print compliance updates and implementation of inspection parameters

QC Supervisor Resume Examples & Samples

Odor evaluation of raw materials and finish products
Review, Develop and implement tools, instruments, analytical methods and procedures in QC
Train analysts to perform laboratory procedures and methods
Gather data, analyze and identify areas of improvement in QC
Conduct out-of-specification and failure investigation and recommend corrective actions
Identify quality problems and recommend solutions
Load, review and maintain Quality data in SAP and other systems
Implement project plans, report on progress, and suggest alternatives where appropriate
All other functions, activities and tasks inherent to the job that have not already been mentioned in order to contribute to the correct running of the Department, and in general, of IFF Benicarlo
BS Degree in Chemistry/Chemical Engineering
Good Sensory skills (odor evaluation)
Proficient in lab based data management systems
Fluent in Spanish and English
3 years in Quality Control Laboratory
Demonstrated experience with GC techniques
Experienced on managing people

Site QC Supervisor Resume Examples & Samples

Establishes implements and maintains site quality program. Coordinates with engineers, suppliers, subcontractors, regulatory representatives and field to ensure that work is done correctly the first time
Assures work on-site meets applicable codes and specifications
Surveillance/Audits of site Contractor Quality Control Programs
Responsible for all aspects of welder qualification on-site testing
Responsible for issuance, control and coordination of Post Weld Heat Treatment (PWHT) and Non Destructive Examination (NDE) contacts
Establishes inspection plan and track inspections/actions identified
Approves site testing such as soils testing, concrete placement and grout breaks, hydro tests, and NDE testing and verify tests are properly documented
Reviews and control documentation for the certification of construction equipment and testing equipment
Reviews turnover packages prior to handoff to Startup
Assists in the coordination of punchlist walkdowns/inspections; establishes and manages the punchlist
Collating Quality Control documentation for final handover to Owner
Interfaces with clients and government officials
Develops and implements quality programs that assist projects and division to meet company and division quality goals and expectations
May act as Quality Consultant for internal and external clients
May act as temporary project fill-in for lower level quality professionals
Provides supervision, training, development, and performance management of direct reports
Acts as mentor to other quality professionals
Implements Safety, Quality, Ethical Standards, and Lessons Learned, and adheres to Performance Management programs in accordance with Division Policies, Standards, and Guidelines
Supports continuous improvement efforts and the change management effects associated with the implementation of improvements
* This position is not available for visa sponsorship
* This professional may have his/her home base anywhere within the U.S. due to being a Field position with high travel/mobilization requirements. This means that this professional will spend the majority of work time at the assigned project location for the duration of the project requiring long-term temporary living close to the project site
Certification in discipline (e.g.: American Welding Society (AWS), Certified Welding Inspector (CWI), Institute for Supply Management (ISM)) or relevant geographical equivalent certification
Previous industrial construction experience
Direct Hire construction project experience

QC Supervisor Resume Examples & Samples

Provides direction to employees and ensures staff is properly trained before assuming job responsibilities
Provides mentoring and performance appraisal to his/her direct reports and participates in staff selection and promotion
Prepares and approves schedule of activities and resources related to testing for in-process, product release, stability, cleaning, validation, investigation and other special studies based on priority and timelines
Conducts comprehensive review of analytical data packets to generate required COAs for product release to maintain critical inventory levels
Exercises independent judgment with respect to conducting laboratory tests for in-process and finished products in compliance with established Standard Test Methods, compendial methods and vendor/partner methods
Maintains organized records of tests performed and results obtained following company policies
Performs and documents laboratory investigations and reports as required
Prepares Quality reports, including analytical reports, Certificates of Analysis (CoA) (for finished product) and stability reports
Improves analytical methods/specifications/instruments and processes on a proactive and independent basis
Writes/reviews Standard Operating Procedures (SOPs), standard test methods (STMs), product specifications and reports to support business needs such as regulatory submissions and APR’s
Understands and complies with all company policies, safety procedures and SOPs
Ensures good relations and communications with all members of the team and responding in a timely fashion to internal and external customers
Understands, observes and complies with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Ensures that procedures are carried out carefully and accurately to eliminate errors
Undertakes any other duties, either for this department or any other department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood
Performs troubleshooting and preventive maintenance on laboratory equipment
Exercises independent judgment with respect to maintaining a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company
Leads complex projects such as CAPA/Change Control requests
Represents functional area in Project Teams and represents Pacira with outside partners
Mentors others, leads and coaches by example through examples of how to do the right thing and do it more efficiently. Provides technical assistance and training to other laboratory personnel
Complies with Pacira’s Policies and Procedures
BA/BS degree from an accredited college or university with 5-8 years of experience or an equivalent combination of education and experience
Must be able to design and implement method validations, statistical designs and to complete entire analytical projects with minimal supervision
Excellent planning, organizational and time management skills
Demonstrate commitment and promote awareness to quality standards
Demonstrate a strong ability to identify, analyze and solve problems. Provide guidance and encourage subordinates to solve minor problems
Communicate effectively the expectations and responsibilities of subordinates
Credible, confident and effective communicator (written and verbal) at all levels
Demonstrated strength in analytical chemistry knowledge with special expertise in one or more analytical techniques (HPLC or GC)
Highly proficient in the use, maintenance and troubleshooting of key analytical equipment (i.e., HPLC, GC, IR, and UV)
Independently able to write in a concise and logical fashion in order to record all pertinent details of experimental procedures and data
Advanced knowledge in multiple areas of cGMPs such as Change Control, Quality events (i.e., deviation, OOS, OOE) and Document initiations/writing sections/revisions/periodic reviews
Highly customer focused and passionate about delivering excellent customer service
Ability to work accurately and independently in a busy and demanding environment, adhering to strict deadlines/timelines
Self-motivated with the ability to work proactively using own initiative and hands on approach with a “can do” attitude
Skilled at promoting team cooperation and a commitment to team success
Demonstrated computer proficiency in word processing, spreadsheets, graphing and trending

Branch QC Supervisor Resume Examples & Samples

Track / Manage all branches QC inspectors’ performance, attendance, monthly bonus and employee reviews. This includes mentoring and training inspectors. Performing internal audits
Prioritize inspectors’ work schedules and coordinate all activities to meet division needs. Schedule overtime as needed to service the divisions
Establish and maintain a good working relationship and open communications with Vice President of Operations for Southwestern US
Establish and maintain open communications with each Branch Director and management team. Host regularly scheduled meetings with branch inspector, branch director, and management team members as appropriate to identify, track and implement corrective actions and other changes designed to improve the efficiency, accuracy, and / or compliance of the branch operations
Train branch inspectors on Quality System Regulation (QSR), Department of Health/ Board of Pharmacy rules and regulations, and Medline Branch policies, procedures and work rules. Retrain as required based on regulation, document and process changes. Monitor to ensure compliance
Collaborate with all assigned locations to consistently improve quality, processes, and documentation among all locations
Hold regularly scheduled conference calls with branch inspectors and Corporate Director of QC to review departmental and divisional information
Maintain currency of QC documents
Review or coordinate review of daily inspection documentation for confirmation that inspection or other activity was performed and documented correctly prior to release of product

QC Supervisor Resume Examples & Samples

Evaluate, certify and verify analytical / evaluation of data for both incoming raw and packaging materials. Responsibility specifically includes prevention of further reprocessing and / or delivery of non-conforming materials when a problem is identified. Reports to Operations and provides immediate disposition and recommendations (if applicable) for non-conforming materials. Authority to stop and prevent further processing / delivery on non-conforming products or processes
Ensure the conduct of all analysis for incoming and in process (if any) raw and packaging in a timely manner. Ensure the identification, traceability and QC status disposition of all inventory items. This includes all raw / packaging materials due to revaluation, slow moving and non-moving items
Generates reports / data / procedures covering QA / QC related activities as specified in the Company’s quality Systems Operating procedures and Quality manual. Assist on the development, implementation and maintenance of the overall Quality System and other regulatory requirements. Develop QA programs like GMP. HACCP, Food Safety, Pest Control etc. Provide relevant trainings to the personnel
Transact QA relevant transactions in the network system such as blocked stocks maintenance (as maybe applicable), and generate reports as necessary. Maintain records. Upgrade SAP, as maybe applicable, periodically or as maybe necessary. Responsible for creating and maintaining the master data of each material in SAP
Creates vendor notifications and coordinates with Purchasing /Planner for the corrective / preventive action implementations. Ensures the timely monitoring of notifications closure
Responsible to the compliance of the atypical, illegal dye testing and other global requirements for raw materials. Ensures that timely submissions of samples are done and provides disposition on the results in coordination with VQDI Team

QC Supervisor Resume Examples & Samples

A minimum of 2 years working experience supervising a team in a regulated QC environment is required
Proven leadership skills with the ability to influence and motivate others
Bachelor’s degree in Chemistry, Biochemistry or Chemical Engineering
A minimum 5 years of laboratory experience Wet chemistry
Proficiency with most wet chemistry techniques and gravimetric assays
Must be able to independently evaluate results from routine analysis and identify problems and potential problems as they occur
Possess a continuous process improvement mindset with the ability to effectively influence change
Proficient in Microsoft Office, LIMS (Lab Information Management System

QC Supervisor Resume Examples & Samples

Supervise, train, and develop staff to enhance quality of employee work, verifies and audits accuracy of test results of the analytical laboratory, ensures uniform methodology and laboratory techniques, and maintains a safe and clean working environment
Interface with Material Control, Manufacturing and Production Planning in order to assign chemists raw materials, in-process blends, startup materials or finished products and establish timely testing and release for production use
Interface with Technical Operations to investigate product and material failure
Generate, approve, and update Standard Operating Procedures and Standard Methods to ensure accuracy and precision of test results and compliance with regulatory requirements
Maintain proper record keeping, calibration, and repair of analytical instruments and laboratory supplies to ensure compliance with Good Laboratory Practices and Good Manufacturing Practices
Investigate Out of Specification (OOS) test results and product quality according to
4-8months

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