Senior Specialist, Quality Assurance Resume Samples

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D DuBuque

Don

DuBuque

96180 Lillie Flats

Dallas

+1 (555) 460 2762

96180 Lillie Flats

Dallas

Phone

p +1 (555) 460 2762

Experience Experience

Boston, MA

Senior Specialist, Quality Assurance

Boston, MA

Kerluke, Turner and Schuppe

Boston, MA

Senior Specialist, Quality Assurance

Work with global quality team to gather complaints records, input into Track Wise system and support global quality team to perform investigation per corp. SOP
Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations
Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
Develop, recommend and monitor corrective and preventive actions
Support Construction in the development, communication and monitoring of Quality priorities
Establish and report metrics related products and processes as deemed necessary by the RQM
Coordinate and support on-site audits conducted by both external and internal providers

San Francisco, CA

Senior Specialist Quality Assurance GMP

San Francisco, CA

Roob and Sons

San Francisco, CA

Senior Specialist Quality Assurance GMP

Assist in development and delivery of metrics and scorecards
Provide support to updates and review of Standard Operation Procedures and other GMP relevant documents
Support analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing
Serve as a point of contact for issue resolution
Support investigations and changes in related stakeholder areas
Support equipment qualifications and computer system validations in related stakeholder areas
Conduct Walkthrough Audits and Internal Audits

present

Houston, TX

Senior Specialist, Quality Assurance Ait

Houston, TX

Marvin, Paucek and Gerlach

present

Houston, TX

Senior Specialist, Quality Assurance Ait

present

Generates a test execution forecast and manages to it, removing any obstacles such as blocking defects
Provides UAT support and ensures that our customers are satisfied thus increasing our perceived value
Guides and provides technical / SME support and training
Ensures test case peer reviews are completed and all action items get resolved
Provide high quality estimates at three different project phase levels. Monitors actual charges to estimates so as to complete work within budget and/or agreed upon variances
Generates a business coverage report to allow the business to understand the test strategy
Identifies any potential test automation candidates that exist for each project

Education Education

Bachelor’s Degree in Scientific

Adelphi University

Bachelor’s Degree in Scientific

Skills Skills

Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
Knowledge of sterile processes and biologic processes desired. Good communication and interpersonal skills
Reviews and approves stability protocols and reports. May serve as the site stability coordinator
Strong problem solving and interpersonal skills and the ability to work independently and with minimal supervision
Ability to monitor trends and recommend corrective actions to cease continued performance issues with equipment and processes
Assists in training new Quality Assurance Specialists
Project Management and change control experience in a Quality function
Experience in pharmaceutical/biotechnology, Computer, IT in a scientific quality or compliance role
Able to present data to others outside and internal working groups to gain consensus on appropriate path forward
Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance

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Senior Specialist, Quality Assurance Ait Resume Examples & Samples

Performs the role of a QA Lead across multiple applications as assigned
Accountable for all test planning and test execution activities performed by test analysts
Provide high quality estimates at three different project phase levels. Monitors actual charges to estimates so as to complete work within budget and/or agreed upon variances
Generates a test execution forecast and manages to it, removing any obstacles such as blocking defects
Provides UAT support and ensures that our customers are satisfied thus increasing our perceived value
Guides and provides technical / SME support and training
Minimum 5 years experience in software quality assurance /system testing
Self starter with ability to handle multiple priorities and projects
Proactive communicator - ability to raise Issues in a professional manner

Senior Specialist, Quality Assurance Resume Examples & Samples

Assure compliance with contract requirements, detect non-complying performance areas and monitor their resolutions by responsible project team and management personnel
Review, analyze and offer resolution for non-conforming materials/items
Review and approve sub-contractors procedures and ITP’s or designate them to responsible persons
Implement and coordinate project specific specialized procedures including maintenance, surveillances and oversight of the corrective action systems
Perform various quality reporting activities
Support Construction in the development, communication and monitoring of Quality priorities
Participate in the safety process
Liaison with Owner QA representatives
Monitor the quality of procured materials and components
Review and control permanent quality records
Provide data as needed for the monthly and final job reports
Supervise & direct Third Party Inspection contracts

Senior Specialist, Quality Assurance Resume Examples & Samples

Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to all GMP areas (i.e. MFG, E&T, QC, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business including the on-going training of junior team members
Independently serves as QA representative in decision making and conflict resolution with junior team members as needed in the absence of the department head
Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. 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
Authorized to suspend any operation when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues utilizing independent judgment and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the Sr. QA Specialist to utilize the input of others to make a final compliance determination
May also be required to communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Sought after by junior team members for guidance in the quality oversight of changes within the Quality Management System including appropriate stakeholder’s reviews are completed such as Regulatory, Client, Area Managers, etc
Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and Approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments
Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems. May be a certified Green-Belt and assigned to lead process improvement initiatives via the BPE program. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements
Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies
Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills
Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business
Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of level. Will provide input on the performance of junior team members to the department head as part of the performance management process

Senior Specialist, Quality Assurance Resume Examples & Samples

Support disposition of raw materials, drug substance, and drug product
Review stability protocols and reports
Minimum education required: AS/BS in a scientific or engineering discipline
Minimum experience required: 3 - 5 years Quality Assurance experience in the pharmaceutical/biotech industry
Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
Proficiency with enterprise systems, i.e., documentation, LMS (learning management systems), deviations, CAPA, etc
Experience in participating in deviation investigations, determining root cause, and developing corrective action plans
Experience with cellular therapeutics

Senior Specialist, Quality Assurance Resume Examples & Samples

Under the guidance of the technology QA manager, verify implementation, monitor effectiveness and review output of tools and techniques to assess, report and mitigate risk and issues in technology used across MRL functional areas and partners. Provide support to the technology QA manager to help ensure that key technology vendors understand and meet minimum requirements set forth in the strategy
Under the direction of the technology QA manager, participate on new technology vendor assessment teams where appropriate
Serves as source of knowledge for technology quality for functional areas and system owners
Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Part 11, Good Laboratory Practice, Good Pharmacovigilance Practice, Good Clinical Practice, Animal Welfare regulations), safety guidelines and company policies and procedures. May assist with the review of relevant SOPs or policies relevant to MRL QA or partnering MRL organizations
Collaborates effectively across areas within MRL QA and on MRL project teams to help facilitate achievement of quality goals and understanding of and application of appropriate regulations
Assist with educational and training materials and sessions to further develop competencies or understanding across MRL QA and partnering MRL areas, where applicable
Proven ability to function autonomously in a matrix model and in a team environment
Proven ability to think creatively and to execute and manage strategic plans

Senior Specialist, Quality Assurance Resume Examples & Samples

Supports timely release of clinical Biologics (DS and sterile DP)
Provides support to updates and review of Standard Operation Procedures and other GMP relevant documents
Serves as a point of contact for issue resolution
Supports investigations and changes in related stakeholder areas
Supports equipment qualifications and computer system validations in related stakeholder areas
Conducts Walkthrough Audits and Internal Audits
Supports the Quality on the Floor program
Supports analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing
Tracks and monitors local operational and quality performance. Escalates issues to the IPT Biologics Quality Associate Director as appropriate
Assists in development and delivery of metrics and scorecards
At least 5 years of practical experience in Quality, Technical Operations, related Business Operations in a GMP regulated environment
Documented experience in sterile manufacturing
High ethical standards, being a role model of business compliance and integrity
Independent work style; proven ability to effectively work within a matrix organization and to leverage expertise from other functions and departments
Strong collaboration skills; proven ability to work across boundaries and to develop sustainable professional relationships on all levels of the organization
Fluency in German and English, both oral and written

Senior Specialist, Quality Assurance Resume Examples & Samples

Maintain an expert level of knowledge related to specialized area of technical expertise or GMP requirements and industry trends as described in applicable worldwide regulations
Advise supported areas on requirements for all assigned project responsibilities as related to quality and Merck standards and communicate project status to management
Independently audit and/or approve GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and Merck requirements. Issue reports as necessary summarizing deficiencies. Work with areas to resolve any audit findings
Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversight of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc
Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval
Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
Independently prioritize activities in support of multiple projects
Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection
Independently conduct GMP facility, systems, or procedural audits/inspections of internal support areas and external contractors and suppliers engaged in manufacturing, testing, holding, or packaging of clinical supplies
Ensure compliance with applicable regulations, policies, and procedures. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends
Review and approve production and analytical documentation accompanying the release of Cell Banks, Seeds, and Drug Substance lots to ensure conformance to appropriate regulatory requirements. Audits information supporting retest or re-evaluation dating for clinical supply materials
Provide technical guidance to senior management in evaluating systems/tools. Assist Development Quality staff and client areas with the technical aspects related to the use of electronic audit tools
Minimum of five (5) years experience with B.S. or three (3) years with M.S. Experience should be in the pharmaceutical/biotechnology industry
Demonstrated analytical, problem-solving and communication (oral/written) skills are required
A working knowledge of current Good Manufacturing Practices and technical aspects of support area are required
Previous experience in quality control/quality assurance; auditing; and/or regulatory submission requirements, is required
Experience supporting outsource partners, external audits

Senior Specialist, Quality Assurance Resume Examples & Samples

Minimum of 3 years pharmaceutical or related industry experience, including work in IT/IS systems validation and/or IT/IS quality
Demonstrated interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Ability to function autonomously in a matrix model and in a team environment
Ability to think creatively and to execute and manage strategic plans
Ability to travel 30-35%
Preferred but not required skills include knowledge of Good Clinical Practice and Part 11 requirements as applied to computer systems used in clinical trials- Prior systems audit experience

Senior Specialist Quality Assurance GMP Resume Examples & Samples

Support timely release of clinical Biologics (DS and sterile DP)
Manufacturing Batch Record Review of Biologics (DS and sterile DP)
Provide support to updates and review of Standard Operation Procedures and other GMP relevant documents
Serve as a point of contact for issue resolution
Support investigations and changes in related stakeholder areas
Support equipment qualifications and computer system validations in related stakeholder areas
Conduct Walkthrough Audits and Internal Audits
Support the Quality on the Floor program
Support analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing
Track and monitor local operational and quality performance. Escalates issues to the IPT Biologics Quality Associate Director as appropriate
Assist in development and delivery of metrics and scorecards
Demonstrated Quality and/or Manufacturing experience in the areas of pharmaceutical/sterile biologics manufacturing or packaging
Knowledge of cGMPs, data management, collection, and analysis
Sense of urgency and the ability to make rapid, disciplined decisions
Demonstrated problem-solving skills with the ability to prioritize, align and simplify; used to manage multiple projects with changing priorities
Strong customer focus and solution orientation; proven ability to deliver practical solutions and to drive results
Refined analytical and consulting skills; demonstrated ability to provide guidance and influence without direct authority
Fluency in German and English, both verbal and written

Senior Specialist, Quality Assurance Resume Examples & Samples

Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Receives general guidance; may receive more detailed instruction on new projects
Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
Establish and report metrics related products and processes as deemed necessary by the RQM
Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)
Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities
Engage and collaboration with operations department to drive quality system and CGMP requirements
Responsible for product release activities per CGMP requirements
Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification
The position will be nights 2am - 10am M-F; located in Boston, MA
Occasional weekends
Overtime required until work is done
Bachelor's of Science in Chemistry or Biology degree preferred but not required
Effective written and verbal English communication skills required
2-3 years’ experience in QA and in a regulated environment preferred - cGMP
Pharmaceutical or medical device experience a plus
ISO experience a plus
Quality Assurance background preferred
Lifting: Frequent lifting between 50-75 lbs
Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment Personal Protective Equipment

Senior Specialist, Quality Assurance Resume Examples & Samples

The position will be nights (12am - 8:30am)
No weekends
Bachelor's of Science in any science discipline preferred
New graduates will be considered
1-2 years’ QA experience in a regulated environment preferred - cGMP

Senior Specialist, Quality Assurance Resume Examples & Samples

The position will be nights midnight or 1am - 8:30am
Occasional Saturday (a couple hours)
Bachelor's of Science in Chemistry or Biology degree preferred

Senior Specialist, Quality Assurance Resume Examples & Samples

Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations
Advise supported areas on requirements for all assigned project responsibilities as related to quality and Merck Standards and communicate project status to management
Independently audit applicable regulatory filings. Ensure compliance with regulatory and Merck requirements. Work with areas to resolve any audit findings
Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements
Identify need for and/or develop SOPs to ensure practices are accurately reflected
Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
Support preparations for regulatory agency inspections
Lead Auditor Requirements include
Consistently demonstrating Merck Leadership Behaviors: Fosters Collaboration, Drive Results, Make Rapid Disciplined Decsions. Demonstrates excellent organization skills. Can effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary. Maintains positive working relationships within CMC auditing team and client areas. Share and apply lessons learned. Holds self and other accountable. Clear communication skills (express in a clear, concise manner)
Demonstrate interpersonal skills to effectively lead an audit
Attend Project Team Meetings
Act as a single point of contact
Provide links of CMC Audit SOPs and SPR trainings (QM SOP 5.01, SOP 840-2020, SPR Training Slides, RAS SOP 840-1019, Risk Based Protocols)
Keep close track of submission timelines and meets deadlines while still maintaining all audit goals
Identify and manage issues on a continuous basis (eg. Unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines.)
Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows
Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)
Prioritize audit sections based on CMC’s request
Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues
Provide tracking, trending and metrics for GMPQ auditing activities, Provide technical guidance to senior management in evaluating systems/tools. Assist GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools
Support Process Improvement initiatives for CMC client and auditing area
Minimum of 5-10 years experience with B.S./M.S., or five (5) years with PhD
Experience should be in pharmaceutical/biotechnology, Computer, IT industry with five (5) years in an IT, Computer, quality or compliance role
Previous experience required to perform job responsibilities may include: computer science, IT, quality assurance, auditing, or regulatory submission requirements
Experience supporting Internal and/or external audits

Senior Specialist, Quality Assurance Resume Examples & Samples

B.S. or M.S. degree in scientific or engineering field
Minimum 10 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
Automation or Information Technology related experience

Senior Specialist Quality Assurance Resume Examples & Samples

Higher level of conceptual knowledge and practices associated with Document Review and Product Disposition
Essential Functions
Responsible for the disposition of domestic and international products
Generate CBER protocols and International Core Documents
Review and approve tests and results in LIMS
Apply necessary batch controls and restrictions to products upon Quality notification of events
Coordinate shipping documentation and sample preparation for domestic and international shipments to applicable health authorities and intra-sites
Perform necessary SAP transactions to indicate task completions or stock status updates to support batch disposition decisions
Review and enter Time Out of Refrigeration for temperature sensitive product into SAP
First person generation of Certificate of Analysis and other pertinent documentation to support Tender request
Issue cases in TraceLink system of vendor issues and First Pass Quality responses, as applicable
Bachelor’s degree in Biology, Biochemistry, Chemistry or other relevant discipline with minimum of three years of cGMP experience
Experience in Operations, Quality Assurance, Quality Control

Senior Specialist, Quality Assurance Resume Examples & Samples

Devise sampling procedures and directions for recording and reporting quality data
Collect and compile statistical quality data
Monitor risk management activities
Attend numerous high level meetings and present result outputs to senior management
Department of Defense or Department of State contractor experience

Senior Specialist Quality Assurance Resume Examples & Samples

Minimum 5 years of experience in a facility that is highly regulated in a Quality Operations or Technical Operations or Manufacturing role or similar experience
Communication and decision making skills: Ability to communicate with all levels of site and MMD organizations through all means (written, verbal, presentations, etc.)
Strong decision-making skills and ability to work with and interact with off-site customers and stakeholders
Detailed knowledge of sterile or aseptic operations
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Demonstrated knowledge of site and MMD Business and Quality systems
Experience interacting with internal auditors or Health Agency inspectors
Competency in use of current MMD or similar industry enterprise resource management system for control product
Experience required in all competencies

Senior Specialist, Quality Assurance Resume Examples & Samples

Minimum of 5 years’ experience in role of Qualification and Validation review and approval
Ability to monitor trends and recommend corrective actions to cease continued performance issues with equipment and processes
Able to assist with the compilation of agency responses in support of responsible activities
Provide Quality Assurance review and approval of all GMP-related SOPs
Ability to drive collaboration and engagement across functions both internally and externally to implement improvement
Act as a resource for colleagues with less experience within own discipline. Solves complex problems and takes a new perspective using existing solutions. Builds knowledge of the company, processes, and customers
Has the ability to effectively manage multiple and changing priorities/projects and ensure timely completion
Knowledge of sterile processes and biologic processes desired. Good communication and interpersonal skills
Proven ability to act as a team or project lead and leads work of others as required
Able to present data to others outside and internal working groups to gain consensus on appropriate path forward
Drives continuous improvement (business and compliance excellence) through the use of lean six sigma methodology and identification of improvement opportunities

Senior Specialist, Quality Assurance Resume Examples & Samples

3+ years of relevant QA technical experience in medical device
3+ years large enterprise or e-business systems experience
Familiar with CFDA related regulations will be required
Strong team work spirit both in local and in headquarter functions
Good English speaking and writing skills

Senior Specialist, Quality Assurance Resume Examples & Samples

Advice supported areas on requirements for all assigned project responsibilities as related to Quality and Merck Standards and communicate project status to management
Identify and manage issues on a continuous basis (e.g. unacceptable source documents, late submission of audit documents, and delay in comments resolution that impacts submission time lines.)
Minimum of 5 years’ experience with B.S./M.S. / PhD
Experience in pharmaceutical/biotechnology, Computer, IT in a scientific quality or compliance role
Extensive working knowledge of cGMPs and technical aspects of support area are required. Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities. Previous experience required to perform job responsibilities may include: computer science, IT, quality assurance, auditing, or regulatory submission requirements

Senior Specialist, Quality Assurance Resume Examples & Samples

The position can start at midnight or 1am M-F located in Houston, TX
Occasional Saturday work
New Graduates might be considered
1-2 years experience in QA and/or regulated environment preferred - cGMP

Senior Specialist Quality Assurance Resume Examples & Samples

Must have strong demonstrated interpersonal and communication skills
Must have very strong relationship building skills
Technical writing experience or equivalent is preferred
Working knowledge or experience in authoring Annual Product Reviews is preferred
Working knowledge of SAP, Trackwise and MIDAS preferred

Senior Specialist, Quality Assurance Resume Examples & Samples

A minimum of 4 years experience in a GMP environment
Knowledge of GMPs as they pertain to Active Pharmaceutical Ingredient manufacturing
Experience with the following: wet chemical, instrumental, microbiological and physical analyses of in-process, intermediates and finished goods, raw materials, water and waste treatment samples
Must be able to provide effective technical direction and training as necessary within the section
Strong problem solving and interpersonal skills and the ability to work independently and with minimal supervision
Please note - This position will require up to 25% Off-Shift coverage including nights and weekend
People manager experience
Coaching Skills to support, influence, and promote the of best practices in the implementation of compliance in a work team
Skills in the application of continuous improvement tools Lean 6-sigma / Toyota Kata