QA Specialist II

12/14/21

Riverview, MI

1500

POSITION SUMMARY:
The Quality Assurance (QA) Specialist II will directly support the implementation, execution, and maintenance of Quality Systems to ensure complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review and implementation of new and revised documentation to support Quality Systems and operations, internal and external audits, and training of personnel to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing as well as process development in the facility.

EDUCATION/EXPERIENCE.
  • Bachelor’s degree in the physical or biological sciences or engineering. Chemistry/Chemical Engineering preferred.
  • 3-6 years of experience in pharmaceutical operations, regulated life sciences, or quality assurance, or an equivalent combination of Quality and technical education and experience is preferred.
  • Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
  • Proficient in TrackWise, SAP and Master Control.

JOB COMPETENCIES.
  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
  • Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
  • Experience interacting with FDA or other regulatory agencies
  • Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.)
  • Must complete tasks independently and notify supervisor of decisions outside of established processes.
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