Quality Assurance Associate (Sacramento, CA)

Quality Assurance Associate

1 year contract

Sacramento, CA

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. We have an exciting temporary opportunity in Sacramento, CA for a Quality Assurance Associate.

 

Responsibilities:

  • Maintains regular communications about activities to Manager and Director as required.
  • Approval or rejection of materials and reagents, intermediates, bulk and finished products in accordance to specifications.
  • Evaluation of batch records as part of the release process that meets specifications.
  • Evaluation of deviation reports relating to manufacturing, premises, equipment and documentation.
  • Ensures release testing has been performed and appropriate documentation is generated and stored with the batch records.
  • Conducts regular internal audits and self-inspections.
  • Implementation and development of electronic QMS in cooperation with GMP director and Management.
  • Develops checks and maintains quality department, premises and equipment.
  • Ensures initial and continuous training of QC personnel.
  • Development and implementation of the GMP quality manual.
  • Develops and implements clinical supply chain procedures in cooperation with Management.
  • Assist in coordinating and overseeing operational compliance monitoring activities, including providing subject matter expertise to address/resolve quality and compliance related questions.
  • Lead Continuous Improvement projects resulting from these aforementioned ongoing gap assessments, or if directly assigned by QA Management.
  • Assist in completing investigations, deviations, Out-of-specification reports, etc.
  • Assist in developing robust CAPAs to minimize reocurrence of non-conformances and to prevent potential systemic compliance issues.
  • Quality Representative in Functional Area Team Meetings, serving as the go-to person answering quality related questions.
  • Author, review and/or approve related documents and  records, such as for example, SOPs, Work Instructions, IQ/OQ/PQ, Analytical Test Methods, Specifications, etc
  • Assists and facilitate information in support of regulatory facility audits and inspections as needed.
  • Support the Change Management process by authoring and managing change controls.
  • Review and approve Validation Plans and Scientific Investigation Reports SIRs , including raw data review of lab test results.
  • Create and deliver training modules of quality topics.
  • Facilitate training related activities from a quality standpoint.
  • Support the training program as required by QA Management.
  • Should be highly knowledgeable in cGMPs, GLPs, GDPs e.g., FACT and FDA

Education:

  • BS in Life Sciences.

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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