Analytical Quality Control Associate

Thermo Fisher Scientific Inc. Lexington , MA 02421

Posted 3 months ago

Job ID :
107462BR

Location :

US - Massachusetts - Lexington

:

Job Description

The VVS division of Thermo Fisher Scientific is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

Job Summary:

This position will work in the GMP compliant QC Laboratories to qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured.

Essential Duties:

Will perform routine assays and testing including ddPCR, SDS-PAGE, ELISAs, osmolality, pH, conductivity, and TOC.

Functions also involve routine and preventive maintenance of equipment, and preparation and purification of commonly used reagents.

The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations.

Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

Perform and evaluate the results of ddPCR assays and other assays related to the safety and release testing of intermediate and final biological products and their stability. These assays must be performed according to written procedures and in compliance with cGMP regulations.

Maintain complete and accurate records of all work performed.

Maintain equipment records as required by procedure.

Write planned variances, deviation reports, track stability data, write reports etc. in compliance with cGMPs. Prepare reagents vital to the continued function of the cGMP QC labs.

Maintain appropriate in-house assay standards including inventory and database of each standard's performance in each assay.

Ensure that training (skills-based, cGMP and Safety) is current and on all performed assays within department, to support commercial production and Pharmaceutical Development needs through highly competent staff. Contributes to the development of new concepts, techniques, and standards.

Considered a consultant (expert) within the group.

Has complete understanding and application of principles, concepts, practices and standards. Review IQ/OQ/PQ protocols and final reports for instrument system upgrades. Generate PQ protocols.

Recommends and guides implementation of functional strategies across group.

Completes tasks where judgment is required in resolving problems and making recommendations.

Provides frequent overall departmental feedback to senior management.

Contributes to the development of new concepts, techniques, and standards

Review IQ/OQ/PQ protocols and final reports for instrument system upgrades. Generate PQ protocols. Recommends and guides implementation of functional strategies across group.

Completes tasks where judgment is required in resolving problems & making recommendations. Provides frequent overall departmental feedback to senior management.

Qualifications:

Bachelor's Degree in Life Sciences or Chemistry At least 1-3 years of related experience or equivalent combination of education & experience.

Extensive knowledge of QC testing principles and procedures, as applicable to focus of position. Extensive exposure to cGMP environment.

Audit experience.

Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.

Strong interpersonal and communications skills; written and oral. Solid understanding of applicable regulatory requirements.

Significant laboratory documentation review and revision experience.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


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Analytical Quality Control Associate

Thermo Fisher Scientific Inc.