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QC Laboratory Associate
QC Laboratory AssociateTekWissen LLC • Vacaville, CA, United States
QC Laboratory Associate

QC Laboratory Associate

TekWissen LLC • Vacaville, CA, United States
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Overview :

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title : QC Associate I / QC Laboratory Associate

Location : Vacaville, CA - 95688

Duration : 12 Months

Job Type : Temporary Assignment

Work Type : Onsite

Summary

With limited supervision, the QC Associate I is responsible for performing direct materials testing in compliance with cGMP regulations. Core duties include execution of laboratory testing, trend analysis, documentation review, discrepancy support (OOS, OOT, OOE), and general laboratory support activities. In collaboration with QC leadership, the QC Associate II contributes to achieving departmental and organizational objectives.

Responsibilities

  • Perform a broad variety of basic and moderately complex tests with documentation according to GMP
  • Review data and assess against established acceptance criteria
  • Perform technical review of peer-generated data
  • Evaluate data to identify trends and / or establish limits
  • Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
  • Identify and troubleshoot technical problems
  • Identify gaps in systems and procedures
  • Receive and provide training
  • Participate in assay transfer and assay validation
  • Perform equipment qualification / maintenance
  • Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
  • Support the maintenance and compliance of operational areas
  • Assure and apply GMP throughout operations
  • Coordinate with customers to support multi-site operational activities
  • Support internal and external audits and regulatory inspections
  • Works to meet schedules, timelines, deadlines
  • Participate in and / or lead group and project teamwork; project and process improvements
  • Write protocols and reports under limited supervision
  • Meets scheduled performance of 95% on time
  • Perform other duties as requested by managers to support Quality activities.

Required Skills

  • B.S. / B.A. degree and 1-3 years experience or Master's Degree plus one year experience or an equivalent combination of education and experience.
  • Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.
  • Strong verbal and written communication skills, ability to organize and present information both formally and informally.
  • Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
  • Routinely exercises sound judgment, reasoning and problem solving.
  • Capable of working under limited supervision and determining own short term priorities.

    • TekWissen Group is an equal opportunity employer supporting workforce diversity.

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