Specialist Quality Control Resume Samples

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K O'Keefe

Kale

O'Keefe

77882 Stuart Rest

Boston

+1 (555) 939 2161

77882 Stuart Rest

Boston

Phone

p +1 (555) 939 2161

Experience Experience

Houston, TX

Specialist Quality Control

Houston, TX

Thompson-Aufderhar

Houston, TX

Specialist Quality Control

Expert in a wide variety of analytical techniques including but not limited to, bioburden and endotoxin techniques, environmental and utilities testing, rapid micro techniques, biological indicators, sterility, growth promotion and identification techniques
Work with the network on the prioritization of work requests
Ensure that all Non-conformances are triaged within the established goal
Responsible for managing NC/CAPA closure within established goal
Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP
Manage and contribute to the achievements of department productivity and quality goals
Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications

Los Angeles, CA

Project Specialist, Quality Control

Los Angeles, CA

Murray, Moen and Hane

Los Angeles, CA

Project Specialist, Quality Control

Manage record keeping of tasks performed related to experiments and relevant data with little input
Interact with and execute projects in conjunction with members of the Quality Control and Research and Development Departments (RnD)
Assist with writing and revising operating procedures
Assist with drafting protocols, executing experiments or studies utilizing established or modified methods, analyze data and contribute to drafting summary reports
Provide administrative support: copying, filing, and archiving records
Assist in retrieval of units from inventory for research use when requested
Perform preventative maintenance, periodic inspections, and testing for proper equipment operation

present

San Francisco, CA

Principal Specialist, Quality Control

San Francisco, CA

Crist Inc

present

San Francisco, CA

Principal Specialist, Quality Control

present

Establishes Quality Control processes and systems according to corporate procedures and establish alignment with Biopharma network
Key Performance Indicator development and monitoring: Defines QC processes to be monitored, and establishes meaningful KPIs related to these processes
Develop Key Performance Indicators for the business
Contribute to query development to assist with analysis or presentations
Communicate with cardinal management personnel to inform them of regulatory procedures
Analyze quality and regulatory related data and provide recommendations for enhancements to processes and coding
Interface with other functional groups within and outside QC to request/share information, provide results and coordinate testing

Education Education

Bachelor’s Degree in Biology

East Carolina University

Bachelor’s Degree in Biology

Skills Skills

Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
Individual and team experience in a Quality or Manufacturing function
Demonstrated technical expertise in analytical testing methodology, equipment and software validation principles, as well as a general understanding of the operation and mapping of controlled temperature units
Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
In-depth working knowledge and application of GMPs/GLPs
Strong written and verbal communication skills
Ability to manage multiple projects simultaneously
Speaks with courage and candor

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15 Specialist Quality Control resume templates

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Senior Specialist, Quality Control Resume Examples & Samples

Must be able to travel outside the United States
Approximately 25% travel with overnight accommodations
Knowledge of construction methods and alternatives and familiarity with machines required to achieve them for both knit and woven product categories
Ability to communicate with, influence and gain support from cross-functional teams
Knowledge of statistical sampling plans, AQL and their appropriate applications
Experience with garment dye, inspecting fabric and cutting
Driver's License required, must provide own transportation to and from local contractors

Specialist, Quality Control Associate Resume Examples & Samples

Perform routine testing and data review of raw materials, intermediates and final products
Utilize written procedures to perform routine and non-routine product testing
Work in accordance with current procedures and demonstrate proper laboratory safety and housekeeping practices
Participate in method development and validation activities to support product testing
Training analysts on analytical methods and operating procedures
Conduct non-conformance and OOS investigations
Contribute to support function of the laboratory
Advanced skills in general laboratory techniques (theory and practice)
Proficient with instrumentation used in chemical analysis, such as FT-IR, UV-Vis Spectrophotomer, Karl Fischer, pH, and microbiology techniques such as gel electrophoresis, cell culture, endotoxin testing, and Bioburden

Specialist, Quality Control & Compliance Resume Examples & Samples

Independently structures and maintains complex data files for accurate reporting on Foreclosure Mitigation Grantees’ compliance and quality control audits so they can be maintained and provided to Congress, NeighborWorks® America staff, the U.S. Department of Housing and Urban Development, network members, and outside grant recipients
Provides reports to the Sr. Manager/ Managers and Foreclosure Mitigation team members as it relates to Quality Control and Compliance of Foreclosure Mitigation programs
Assists in the Foreclosure Mitigation Quality Control and Compliance review processes by assisting with review of contractor reports, Grantee audit reports, Grantee site visit reports and responses of Grantees. Provides independent analysis of responses from Grantees and recommendations to the Sr. Manager, Quality Control and Compliance regarding whether findings can be considered “cured.” Communicates this directly with Grantees
Provides data analysis and support to Sr. Manager in analysis of Grantee and audit contractor program data. Creates, implements, and maintains tracking system for this work. Communicates analysis to the Quality Control and Compliance Sr. Manager and the Foreclosure Mitigation program team. Provides recommendations about the implications of the data analyzed
Provides analytical and specialized support for special projects, including Foreclosure Mitigation grant application evaluation processes
Researches and analyzes impact/achievements and presents findings, and makes recommendations to the Sr. Manager Foreclosure Mitigation Quality Control and Compliance; Sr. Director, Foreclosure Mitigation, Quality Control and Compliance and the Vice President, National Initiatives, Foreclosure Mitigation
Provides direct customer service to Foreclosure Mitigation Grantees by responding to telephone calls, email inquiries and requests for information. Provides other technical assistance to Grantees as they respond to audit reports
Accurately records and tracks all information as it pertains to the Quality Control and Compliance of Foreclosure Mitigation Grantees
Assists with the day-to-day program monitoring for Foreclosure Mitigation Grantees, including ensuring Grantees are aware of and adhering to program requirements
Independently researches, coordinates, and responds to requests for information about the Quality Control and Compliance of Foreclosure Mitigation grant programs from internal audiences in a timely fashion

Specialist, Quality Control Resume Examples & Samples

Responsible for overall Regulatory Compliance in the area of Chemistry and Formulation
Develop, implement and maintain procedures for laboratory functions
Perform Production Review Investigations relative to formulation non conformances
Maintenance of department budgets
Perform and evaluate Validations
Perform Engineering tests and hypothesis testing and statistical evaluations
Perform stability studies
Assist in troubleshooting efforts
Responsible for the implementation and maintenance of quality systems relative to formulation, water system and chemical analysis
Responsible for the completion of the appropriate documentation, i.e. batch records, engineering tests, validations production record reviews, investigations and customer complaints
Must have awareness and respect of all company policies and safety rules
2-5 years in analytical chemistry
Experience in operating, GC and HPLC
Basic commercial software packages, MS-Word, MS-Excel and Chemstation Software
Must have good written and oral skills, and the ability to organize and follow up
Must have outstanding records in Attendance, Punctuality and Discipline
Must have gone through safety training and awareness

Specialist, Quality Control Resume Examples & Samples

Responsible for overall Regulatory Compliance in the area of Microbiology
Maintenance of the Calibration program for laboratory equipment
Perform Production Review Investigations relative to formulation non-conformances
Maintain Quality Reports
Perform Engineering tests, hypothesis testing and statistical evaluations
Maintain and implement efforts in housekeeping, and safety programs
Perform Internal Audits as assigned
2-5 years in Microbiology and/or sterilization
Basic commercial software packages, MS-Word, MS-Excel and Chemstation SoftwareMust have good written and oral skills, and the ability to organize and follow-up

Principal Specialist, Quality Control Resume Examples & Samples

Coaches and mentors departmental employees
Leads coordination and communication between departments, across functions and across BI sites
Plans, organizes, and implements projects within specified objectives
Provides guidance to all GMP areas (i.e. MFG, E&T, PS, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified
Ensures staff are properly trained
Develop Key Performance Indicators for the business
Responsible for both executing the tactical operations and overseeing QC team members. Leads/participates in investigations, solve technical problems and identify aberrant results to management. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner
Must be able to pro-actively identify issues to prevent missed timelines
Provides guidance to MFG, E&T, and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QC and the business including the on-going training of junior team members. Work with other QC groups to provide support, review of data, sharing of information/scheduling
Independently serves as QC representative in decision making and conflict resolution with junior team members as needed in the absence of the department head
Quality Control process improvement and implementation
Establishes Quality Control processes and systems according to corporate procedures and establish alignment with Biopharma network
Serves as the site Change Leader for new QC initiatives; identifies barriers to successful implementation and works to resolve them
Pro-actively engages the site to uncover issues and concerns relating to QC, and facilitates resolution and continuous improvement
Identifies and resolves critical issues (including deviations, investigations, OOS, etc.), as appropriate and typically works on complex Major issues. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations
Accountable for Test results. Provides guidance and control directives regarding remediation activities required to continue testing. Is required to resolve critical issues utilizing independent judgment and decision making as a senior member of the department. Serves as the final decision-maker utilizing the input of others to make a final compliance determination
Auditing and compliance
Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies. Prepares data and presentation for periodic management review for the site and QC functional areas. Conducts meetings, to ensure business remains compliant with all organizational standards and relevant regulations
Participates in inspection readiness activities. Presents QC review process, QC risk management program, deviation/CAPA and change controls to auditors and inspectors, to prove the organization's compliance with relevant regulations
Key Performance Indicator development and monitoring: Defines QC processes to be monitored, and establishes meaningful KPIs related to these processes
Collects quality data for Site BSC (Balanced Score Cards) and various Quality dashboards (e.g. Biopharma Quality Dashboard); defines KPIs to be reported and the intervals at which they will be measured
Serves as the Team Lead (project manager) during planning and implementation of improvement projects relating to QC KPI's; provides communication of issues, project updates and changes to site management, stakeholders and users. Represents QC on multi-disciplinary project teams
Applies project management skills and concepts to lead or manage projects with an interdisciplinary project team from planning stage to project completion
Trains Fremont employees on: QC risk assessments, Deviation/CAPA and Change Control systems. Develops training materials to ensure high level of quality and consistency for deviations/CAPAs and change controls

Senior Specialist Quality Control Resume Examples & Samples

Must have a minimum of 2 years experience in a laboratory
Strong interpersonal, relationship building and leadership skills
Must have a good communication, negotiation and persuasion skills
Must be fluent in both spoken and written English
Strong understanding of GMP requirements
Experience in working with external parties
Able to demonstrate organizational skills and is self-motivated

Senior Specialist Quality Control Resume Examples & Samples

Minimum 5 years experience working on Biologics Release Testing in compliance with Good Manufacturing Practices (GMP)
Experience with rodent handling and injections via the intraperitoneal (IP) and intracranial (IC) routes intramuscular (IM), intravenous (IV), and subcutaneous (SQ) routes of administration observations
Experience with rodent observations of physical signs, differentiating and understanding normal rodent behavior and behavior induced due to compound effect
Experience with gross examinations and necropsy
Position requires some rotating holiday and weekend Saturday, Sunday work
Strong computer, scientific, organizational, and documentation skills
Excellent interpersonal and communication (oral and written) skills and attention to detail

Senior Specialist Quality Control Resume Examples & Samples

Independently works on projects with guidance from LTS senior staff related to the development of new and improvement of existing assay methods for licensed and developmental products
Qualifies critical reagents and controls for use in release and stability testing. Incumbent independently performs and completes reagent qualifications by authoring protocols with guidance from senior staff, performing/organizing experiments and authoring reports
Conducts experiments and documents results for the purpose of validating enhancements to methods used in release and stability testing. Partners with appropriate regulatory, MRL and LTS senior staff to perform analytical assessment and transfer of new methods to Laboratory Operations
Under the guidance of LTS senior staff, develop, validate and transfer improved analytical methods to Laboratory Operations
With guidance from LTS senior staff, performs analytical investigations in relation to quality issues that may be involved in product recalls, market withdrawals, process abnormalities and manufacturing or packaging process changes
Proactively supports Laboratory Operations during investigations of invalid/atypical results or shifts/trends in the performance of analytical testing
Plans and carries out assignments. Incumbent strives to work independently in the design of experiments and seeks guidance on protocol design and data interpretation. Strives to provide creative solutions to problems that may arise during an investigation
Demonstrates the ability to work proficiently with the Quality business systems
Authors comprehensive technical documents requiring minimal review and revision
Demonstrates leadership to independently implement, execute and manage projects
Independently executes training and implementation of new and existing technology for routine analytical testing
Responsible for using safe laboratory techniques and maintaining work area in a clean, orderly manner adhering to WP Safety Policies and cGMPs
Conducts all analytical and project responsibilities according to the highest quality standards
Partners on analytical problem solving while insuring compliance with cGMP and regulatory requirements to support the evaluation of Merck products for safety, efficacy and potency
Responsibilities include proper documentation of test results, related data and necessary calculations in a manner consistent with cGMPs
A background including analytical troubleshooting, potency method improvement and validation, statistics and cGMP regulations is preferred
Specific Methods: Biochemistry Methodology, ELISA, Western Blot, Protein assays, Gel assays, Densitometry, Endotoxin (LAL)
A background including experience with analytical testing and analytical troubleshooting for the following analytical test methods: Statistical Software expertise (JMP, Minitab, etc.), Liquid Handling equipment, Capillary Electrophoresis, Cell Culture, ELISA Based assays

Specialist Quality Control Resume Examples & Samples

Expert in a wide variety of analytical techniques including but not limited to, bioburden and endotoxin techniques, environmental and utilities testing, rapid micro techniques, biological indicators, sterility, growth promotion and identification techniques
Experience of managing project groups and leading high performing teams and delivering results
Experience with pharmaceutical Microbiological technologies and methods
Qualification of analytical equipment and related testing functions. Prior experience in rapid micro techniques is an advantage
Co-ordinates & plans activities related to the successful method transfers and optimisation of Microbiological Methods into the Amgen site
Compliance with Standard Operating Procedures and Registered specifications
Ensure the laboratory is operated in a safe manner
Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP
Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures
Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing
Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
Have 7 years of experience in a pharmaceutical/healthcare Laboratory or a related technical function preferably in an Aseptic or microbiologically controlled environment
Strong background in microbiology and aseptic manufactured is required
Experience with Trackwise, Change Control Systems, EDMQ and SAP an advantage
Experience with Regulatory inspections and interacting with inspectors
Experience leading cross-functional teams
Experience working with teams and influencing decision
Skilled in the use of problem solving tools/techniques
Country (State/Region)

Senior Specialist, Quality Control Resume Examples & Samples

Quality Control project management and execution
Laboratory scheduling activities
Participate in the investigation of cross-functional teams to determine root cause of exception reports and laboratory investigation reports
Serve as a technical subject matter expert (SME) in Microbiological testing of raw materials, stability, final product
Provide technical expertise in the development of test method validation protocols and supporting procedures
Work closely with quality and other departments to ensure appropriate root cause and CAPAs are determined
Author/revise SOPs, methods, protocols, and trend reports
Provide support to all Quality Control related audits from external and regulatory agencies
Execute and manage the Change Control workflow and Controlled Document change process and assess all changes prior to implementation
Identify Continuous Process Improvements to maximize efficiencies and streamline processes within the Quality Control department
Minimum of 6 years experience in a laboratory environment
Understanding and application of GLPs and cGMPs
Experience with aseptic technique
Prior experience in the performance of environmental and water systems monitoring

Specialist Quality Control QC Metrics Resume Examples & Samples

Champion the Generation, Management and Reporting of QC Metrics
Locally own and manage the business process for Metrics
Proactively support QC by developing, executing and maintaining metric activities
Ensures the integrity of the supporting data used to provide Metrics for QC Dashboard
Provide Metrics reports as per the planned schedule for the QC organisation and associated projects
Seeks out opportunity to improve the processes that they own
Supports Audits and Inspections with regard to preparation and participation
Builds relationships and partners with similar roles in the network to share lessons learned and improvements
Works with minimal supervision but knows when to escalate or look for support
Key contact for ADL QC Metrics within the wider Amgen network
Acts as an advocate for ADL for global updates to tracking and trending procedures to ensure any new processes are well communicated and fit for purpose with a focus on continuous improvement
Escalates any trends identified and partners with the functional areas to put action plans in place
Hold a third level qualification in a Science related discipline
Have minimum 6 of years’ experience in Biotechnology/ Pharmaceutical/ GMP environment
Excellent Computer Skills ( e.g. Excel, Word, MS Office Power Point, MS Office Suite etc) and working knowledge of EDMQ or a similar electronic document management system
Knowledge of Laboratory Enterprise Systems would be advantageous e.g. LIMS
Knowledge of Data Bases, Query building and reporting tools
Knowledge of the statistical tools used in the interpretation of laboratory data
Ability to work with minimum direction
Possess key competencies to include Planning and Organisation, Communication, Teamwork, Flexibility

Specialist, Quality Control Resume Examples & Samples

A minimum of five years related experience including a thorough knowledge of procedures, paperwork, and specific laboratory testing experience
Ability to work independently and follow oral and written instructions
Ability to work on a team with people from both inside Quality Control as well as other departments such as Research and Development and Manufacturing
Ability to independently prepare written reports for submission to United States Department of Agriculture (USDA) and other agencies
Proficiency with advanced laboratory techniques and procedures relating to USDA 9 Code of Federal Regulations (CFR) testing of veterinary biologicals preferred

Specialist, Quality Control Editor Resume Examples & Samples

B.A. in English, Communications, or Language studies or equivalent experience
Previous experience as a Website Designer, editor, or copy editor
Previous experience in a fast-paced production environment

Specialist Quality Control Resume Examples & Samples

Support capital projects and coordinate equipment projects for assigned area within Laboratory Operations
Initiates and participates in equipment related investigations and quality notifications to ensure compliance with cGMPs and regulatory requirements to support the quality, safety, efficacy, and potency of Merck products
Individual and team experience in a Quality or Manufacturing function
Demonstrated technical expertise in analytical testing methodology, equipment and software validation principles, as well as a general understanding of the operation and mapping of controlled temperature units

Specialist Quality Control Resume Examples & Samples

Resolve bottlenecks related to key changes
Participate with Sites, Corporate and Development to execute various initiatives
Proactively assess processes for continuous improvement opportunities and use expertise to provide options
Construct and own GMP materials relating to area of responsibility
Cross train in LIMS, Empower, CIMS, LMES, and/or Tecan templating to support the MDG team and the global QC network
Provide applicable performance metrics
Drive global alignment of the QC systems
Work with the network on the prioritization of work requests
Train site SMEs to fine tune templates
Ensure training is up to date
Master’s degree and 3 years of Quality or Information Systems experience OR
Bachelor’s degree and 5 years of Quality or Information Systems experience OR
Associate’s degree and 10 years of Quality or Information Systems experience OR
High school diploma / GED and 12 years of Quality or Information Systems experience
Familiarity with Power Point, Visio, Documentum, Trackwise, and laboratory documentation systems
Advanced capability in project management tools
Able to successfully manage workload to timelines
Experience in a laboratory environment
Experience in Bioassay and Immunoassay testing
Experience in creating Tecan scripts
Experience in Manufacturing Practices
Experience in Empower, LIMS, and/or SmartLab
Knowledge of Data Integrity Requirements of QC systems
Good Manufacturing Practices
Data Integrity Requirements of QC systems

Specialist Quality Control Resume Examples & Samples

Own and support change control records impacting Quality Control
Non-Conformance and CAPA
Ensure that all Non-conformances are triaged within the established goal
Responsible for authoring investigation reports and execution of corrective actions
Responsible for managing NC/CAPA closure within established goal
Monitor and communicate incident trends
Review equipment/system Root Cause Analysis investigations and support trend evaluations
Master Data Group (MDG) Templating
Participate on the assessment or implementation of special projects or initiatives
The primary responsibility require templating in LIMS, Empower, CIMS, LMES and/or Tecan templating to support the MDG team and the global QC network
Doctorate Degree OR
Master’s degree and 3 years of Quality and / or Information Systems experience OR
Bachelor’s degree and 5 years of Quality and / or Information Systems experience OR
Associate’s degree and 10 years of Quality and / or Information Systems experience OR
High school diploma / GED and 12 years of Quality and / or Information Systems experience
Experience in Quality Systems- NC/CAPA and CCMS
Experience in QMTS

Specialist Quality Control Resume Examples & Samples

Reviews and evaluates laboratory quality control related to methods, procedures, documentation and equipment
Bachelor's Degree in Medical Technology or related field, required
American Society for Clinical Pathology (ASCP) registry, preferred
Must meet NYSDOH Technologist requirements
Minimum of three (3) years progressively responsible Laboratory experience, required

Specialist, Quality Control Resume Examples & Samples

Three to five years animal laboratory experience in compliance with Good Manufacturing Practices (GMP)
Experience with rodent and rabbit handling, injections, observation and recording of physical signs, and gross examinations and necropsy
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment

Senior Specialist, Quality Control Resume Examples & Samples

For candidates with a Bachelors degree, a minimum of 3 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
For candidates with a Masters degree, a minimum of 2 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
Progressive and demonstrated Quality decision making responsibility

Specialist, Quality Control Resume Examples & Samples

Provides oversight to team members to ensure compliance with quality and reliability standards
Uses ability as a skilled specialist to contribute to the development of techniques
Recommends modifications to existing, or suggests new, standards, methods and procedures
Key point of contact with management and engineering regarding failure trends and system issues
Work is completed independently to determine appropriate procedures for new assignments

Senior Specialist, Quality Control Resume Examples & Samples

Develops, validates and executes analytical and wet chemistry methods. Such as: HPLC, FTIR, GC, UV-Vis, and other assay
Develops, creates and approves instrument/equipment qualification protocols for new equipment/instruments. Prepares the applicable procedures
Review QC equipment qualification and maintenance records for compliance to procedures and specifications. Investigate and troubleshoot Quality Control methods related to instrument issues
Qualify and implement new equipment and technology from support groups to the QC laboratory
Develop and author complex and explicit documentation for new and current procedures and technical reports
Compile and analyze data use scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problem resolution. Suggest process improvements to QC management
Assist in special projects (i.e. validations, microbiological studies, etc.)
Provide training to Analysts and Associate Analysts as necessary
Work weekends, overtime, and holidays, as needed
Back up Analysts and Associate Analysts with routine testing, as needed
Provide back up for Supervisor, as needed

Lead Specialist, Quality Control Resume Examples & Samples

Medical Technologist (ASCP) or equivalent certification preferred
Minimum of four years technical experience in a testing laboratory required, five or more years of laboratory and/or Quality Control experience preferred. Will be required to meet specific state requirements
Possess superior written and verbal communication skills and basic leadership abilities
Proven skills in critical thinking, problem solving and decision making
Use of good sound judgment
Ability to promote cooperative work environment with laboratory staff
Frequent standing, walking and sitting
Good close vision required. Clear complex speech and good hearing required

Associate Specialist Quality Control Compliance Resume Examples & Samples

Responsible for actively contribution to realization of corporate policy on safety, health and environment
Demonstrates personal commitment with respect to working safely, healthy and environmentally friendly
Bachelor’s degree (HLO) preferably in Biotechnology, Chemistry, or relevant field
At least five years of relevant experience in Quality Control in pharmaceutical industry
Experience with documentation system and preferably with SAP
Knowledge and experience with quality and compliance guidelines, cGMPs
Knowledge of industry guidance and respective regulations of Analytical Methods Validation, Equipment Qualification, Quality Control, Quality (Management) Systems, Documentation, QC Deviations/ CAPA and Change Controls
Technical knowledge in testing techniques
Experience with Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma
Effective project management planning skills and ability to communicate on prioritization and bring others on the same page
Ability to work under minimum supervision, team work oriented and a hands- on mentality
Strong focus on clients and end-user
Good communication skills, pro-active and flexible
Excellent interpersonal and communication skills (oral and written) in Dutch and English

Project Specialist, Quality Control Resume Examples & Samples

Interact with and execute projects in conjunction with members of the Quality Control and Research and Development Departments (RnD)
Assist with drafting protocols, executing experiments or studies utilizing established or modified methods, analyze data and contribute to drafting summary reports
Observe experimental results in progress; record observations, trouble shoot when necessary and understand when to escalate problems to stakeholders
Assist in retrieval of units from inventory for research use when requested
Manage record keeping of tasks performed related to experiments and relevant data with little input
Perform calibration and validation/verification of equipment
Provide administrative support: copying, filing, and archiving records
Validate processing and testing methodologies
Handle Liquid Nitrogen (LN2) utilizing personal protective equipment and good safety practices
Set up testing assays for monthly process control as directed
Bachelor of Science degree with 2 year laboratory experience or equivalent Bachelor degree with relevant laboratory experience and course
Willingness to build knowledge related to stem cell science and newborn tissue banking through meeting with RnD members, participation in QC/Scientific and Medical Affairs journal club, attend identified webinars and, on occasion, reading select scientific articles identified by RnD members
Demonstrated desire to gain experience in experimental protocol design and execution through informal mentoring
Demonstrated ability in relevant laboratory methods including cell culture related techniques
Ability to work independently, apply critical thinking and synthesize complex information, proactively troubleshoot, seeking guidance when necessary

Specialist Quality Control Resume Examples & Samples

Bachelor’s degree and 5 years of Quality experience OR
Associate’s degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience
Previous experience in a regulated GMP environment
Experience executing analytical test methods for protein analysis (Peptide Mapping, Glycan Mapping, etc.)
Operation, maintenance, and troubleshooting experience with CE, GC, GC-MS equipment and instrumentation
Demonstrated technical writing skills within a highly regulated environment
Demonstrated investigational and problem solving skills related to nonconforming events
Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
Exposure to regulatory agency inspectors (or participation in regulatory agency audits)

Specialist, Quality Control, Night Team Resume Examples & Samples

Perform in-process and documentation review of all laboratory testing including reagent qualification, proficiency testing, non-standardized and investigative testing, and reagent evaluation studies
Evaluate validity of test results prior to transfer, and release valid test results to customers
Ensure the accurate, reliable and prompt reporting of test results
Perform in-process review including reagent/supply verification, equipment daily maintenance verification, pre-operational checks and evaluation of samples for acceptable age and type
Review all testing documentation ensuring test validity, performing second technologist/technician test result entry for manual tests, manual entry of automated tests, and verifying critical control value entry in the Laboratory Information System (LIS)
Release, extract and transmit test results. Determine which samples are not released for extraction and identify the cause of any missing results
Notify supervisor immediately of any discrepancies in testing, sample management and/or pooling records that may impact the acceptability of results
Investigate and ensure proper corrective action is identified and taken in compliance with all policies, procedures and regulations
Notify other facilities as necessary
Verify reagent qualification panels react as expected, and document approval of the qualification batch. Enter reagent QC in the LIS
Review, evaluate, collate and submit proficiency testing results to Supervisor. Maintain documentation associated with proficiency testing
Maintain detailed knowledge of laboratory policies and procedures
Participate in continuing education programs and required training/retraining as necessary
Assist in organization of work and assignments for Quality Control Specialists I. Participate in special projects, committees and validations as required
Bachelor’s degree from an accredited institution in chemical, physical, or biological science, medical technology or the equivalent experience required. (California only: Current California Clinical Laboratory Scientist license required.)
Minimum of three years technical experience in a testing laboratory required, four or more years of laboratory experience preferred
Will be required to meet specific state requirements. Degrees from foreign institutions will require credential equivalency evaluation
Ability to read, understand and follow complex procedures and understand the operation of complex instrumentation
Analytical, numerical and reasoning abilities necessary
Manual dexterity sufficient for writing and computer use necessary
Good close vision required

Principal Specialist, Quality Control Resume Examples & Samples

Assist in handling routine responses to data and information requests
Quality and Regulatory
Technical questions related to the Product Master Item File items and relevant data
Technical questions from both internal and external customers
Participate in corporate wide initiatives related to quality and regulatory affairs
Communicate with cardinal management personnel to inform them of regulatory procedures
Integrate new quality and regulatory processes into the Product Master Data department
Understand the system structure at Cardinal Health as it relates to the utilization of the product master data and supporting third party data files
Interface with IT to assist with development of the product master item file database system enhancements with regard to quality and regulatory needs through Microsoft Access and Excel programs
Analyze quality and regulatory related data and provide recommendations for enhancements to processes and coding
Cross train and support other Database Editor for data related tasks/projects and act as a back-up when needed
Contribute to query development to assist with analysis or presentations
Conduct information sessions for internal and external customers as needed
Bachelor’s degree required. Bachelors in Pharmaceutical Sciences preferred
2 years of experience within the Healthcare industry, Pharmacy technician preferred
Hazardous Materials, Quality and Regulatory or similar experience preferred
Knowledge of Microsoft Office Applications; Word, Excel and Access, PowerPoint, Outlook
Ability to mentor and coach staff
Knowledge of pharmaceutical products and medical devices
Detail Oriented, Flexible and Organized
Interpersonal communication skills
Proven analytical ability coupled with experience in problem solving and issue resolution
Independent worker
Strong written, oral and presentation skills