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Job Details

Manager Quality Control Lab Systems

Company name
Thermo Fisher Scientific Inc.

Location
Middletown, VA

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Job Description

Position Summary:

Supervise timely testing and release/rejection of raw materials, intermediates and finished products utilizing clinical chemistry, immunoassay, analytical and microbiological methods and automated systems for testing at the Middletown site. Assure technical correctness of all testing/value assignment functions to ensure products comply with established internal and external requirements required to maintain consistent product performance and quality in the field. Provide technical expertise to assure the rapid solution of product and or control system problems. Facilitate the timely response to OEM customer complaints including the CAPA plan and customer focus.

Major Responsibilities:

Direct Quality Control testing of raw materials, intermediates and finished products requiring testing by automated clinical chemistry and immunoassay methods, analytical chemistry and microbiological methods.

Provide technical expertise to aid in making decisions on the release of raw materials, intermediates or finished products. Work with appropriate teams to make recommendations and/or formulate action plans for investigation and disposition of materials which do not met release specifications.

Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values.

Develop and implement Quality Assurance policies and procedures supporting

21 CFR 820/

ISO13485/MD-SAP/CE

compliance.

Review and approve customer specifications for incorporation into the Middletown specification system.

Work with Product Development and Quality/Regulatory Affairs support to interface new product/equipment into QA operations so that appropriate systems are in place.

Develop qualification plans for changes in existing products or raw materials. Coordinate the qualification requirements with other QA teams; document the qualification recommendation to trail review staff.

Serve as QC representative on cross-functional, PPI and product integration teams.

Streamline reagent release activities and create efficiencies to assure rapid completion of lab testing with a minimum of staff while maintaining technical accuracy and correctness.

Provide needed support to manufacturing over all shifts and work schedules. Develop and maintain a flexible organization such that fast changing manufacturing priorities can be accommodated with a minimum of disruption. Work with manufacturing on a daily basis to meet their scheduling needs and avoid reagent backorders.

Coordinate the training and cross training of lab personnel to ensure career development and method coverage. Set goals, conduct performance evaluations, provide improvement plans and participate in discipline as required by the manager and HR.

Assure that all lab instruments are audited in a timely manner and in compliance with appropriate regulations. Assure that software is adequately documented and validated.

Take responsibility for specific projects. Plan, perform and evaluate experiments as needed.

Develop and monitor appropriate metrics on lab performance and efficiency. Implement practical process improvements to reduce lead times and improve turn-around times for lab testing.

Perform other duties as assigned.

Minimum Requirements/Qualifications:

B.S. Degree in Chemistry, Biology, Clinical Chemistry or related science with 10 years related experience of which five (5) must have been in a supervisory leadership role.

Physical Requirements:

Normal office environment.

Position may require frequent communication and walking to other areas in which designated PPE will be required.

Position will require sitting and standing.

Employee may occasionally lift and/or move up to 10 pounds.

Critical Hiring Criteria:

Ability to use critical judgment in a very demanding product or process problems under immediate time constraints.

Demonstrated leadership and supervisor skills and an ability to delegate work assignments to employees.

Knowledge of the diverse operations of diagnostic Quality Assurance and Quality Control principles, statistic and computerization.

In-dept knowledge of reagents and instrument systems, as well as the analytical support instrumentation.

Broad technical knowledge encompassing diverse product lines and a proven ability to troubleshoot complex problems.

Excellent verbal and written communication skills.

Ability to rapidly and effectively resolve manufacturing and/or procedural problems.

Excellent organizational skills and be detail oriented.

Strong “people skills” to be able to deal with various personalities and levels within the organization.

Ability to review current processes and implement productivity improvements.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Company info

Thermo Fisher Scientific Inc.
Website : http://www.thermofisher.com

Company Profile
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

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