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PDS Tech Inc Quality Specialist II in Detroit, Michigan

PDS Tech, Inc. is seeking Quality Specialist II

How will you make an impact?

  • As a Quality Specialist II, you will have the opportunity to support a life science manufacturing facility in Detroit with specialized Quality Assurance services. You will make an impact by supporting various quality assurance activities including releasing raw material and finished good product, conducting batch record reviews and final product verifications, document control processing, support quality improvement initiatives, maintain quality presence on the production floor and overall responsibility towards maintenance of the quality system in controlled manufacturing environment.

What will you do?

  • Responsible for the release and disposition of material, batch record review, and QC data review and disposition.

  • Conduct final product labeling reviews and verifications at times of release.

  • Responsible for management of documentation life cycle including storage, archival, removal, destruction of documentation as required per standard procedure.

  • Maintains and coordinates documentation as required by the manufacturing facility such as Batch Records, Logbooks, Calibration Recordsetc, and other documentation activities as required.

  • Support initiation of Standard Operating Procedures (SOPs) and other related sites-controlled records.

  • Ensure compliance of the Quality systems at the Detroit site to cGMP and ISO 13485:2016 requirements.

  • Maintain responsibility and ownership of the documentation management system facilitating revisions and creation of documents. Perform administration duties of the Document Control and Change Order activities.

  • Ensure compliance of the Learning Management System to sites procedures and standards.

  • Tracking of training records within the site.

  • Support all internal and external audits and ensure compliance of the audit program with site and standards.

  • Lead/Support Quality (Gemba) walk-throughs to enhance compliance.

  • Manage Stability Program and performs review of stability test data.

  • Enhance traceability of the Deviation (planned) with product releases.

How will you get here?

Minimum: Bachelor of Science (BS) Degree in Business or a scientific discipline is. Other relevant credentials or experience may be acceptable.

  • A minimum of 2-3 years prior experience in a Quality Assurance role. Preferably, in a cGMP Pharmaceutical/Biotech/or Life Science site.

  • Strong knowledge of ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).

  • Prior experience with batch records reviews and releases of raw material and finished good products.

  • Prior experience with an electronic Quality Management system software utilized for processing of documentation creation.

  • Lean Sigma Green Belt certified a plus.

  • ASQ certification is a plus.

Knowledge, Skills, Abilities

  • Excellent verbal and written communication skills and ability to collaborate across different levels of the organization.

  • Knowledge of cGMP regulations and ISO standards.

  • Excellent organization skills with strong attention to details.

  • Ability to multitask efficiently to support production demand.

  • Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.

  • The job may require standing for long periods of time.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.