8 days old

Quality Assurance Director

Kelly Services
Fresno, CA 93744
Kelly Services is actively recruiting for a cGMP Quality Assurance Director with experience within pharma, biotech, personal care, tobacco and/or cannabis industries.

The cGMP Quality Assurance Director will be responsible for the management and oversight of the Quality Management System (QMS) specifically functioning within the GMP space among other laboratories . Responsible for strategic development and leadership of Quality within a GMP and GLP environment, through policies and training for technical and operational staff. Be proficient in the ISO / IEC 17025, USDA, 21 FDA CFR & CFR part 11 guide for testing laboratories.

**Responsibilities includes:**

1. Conduct risk assessments and develop plans for remediation to mitigate and address risk.

2. Manage customer complaint process and ensure effectiveness of customer deliverables.

3. Support Quality group with department strategy development, objectives, goal setting and, project prioritization activities.

4. Interface with all technical departments to ensure compliance to all quality standards, including the qualification of personnel to quality policies and procedures.

5. Identify training needs and organize training interventions to meet quality standards.

6. Draft, maintain, and disseminate policies and procedures.

7. Perform audits of all quality system documentation and personnel for general quality system compliance, including methodology and work instructions.

8. Direct and approve corrective actions initiation, follow up on critical audit findings to ensure appropriate actions were taken to resolve the issues identified.

9. Review and evaluate investigations related to Client Complaints and laboratory non-conformances.

10. Coordinate external audits, acting as the companys representative for issues related to the Quality Management System.

11. Manage inspection results and responses to findings from audits performed by clients, regulatory agencies and accrediting bodies.

12. Assist in refining and collating Quality metrics data from the GMP laboratories for tracking and trending purposes.

13. Assist in populating and maintaining the QMS system with updates and other functions as appropriate.

14. Responsible for ensuring preparedness for surveillance audits as they occur and work closely with each facility Laboratory Manager and Technical Manager as the key contact for external auditor.

15. Have the ability to provide hands on training on all parts of the quality system as needed and requested.

16. Play a key role in thinking strategically and assist in process execution that will improve efficiencies for the network as it relates to quality.

17. Follow up on major and critical audit findings to ensure that appropriate actions have been taken, and that the issues identified, have adequately been resolved.

18. Ability to interpret technical data and provide summarization.

**Requirements include:**

+ BS degree minimum or MS degree preferred in Microbiology, Chemistry, Food Technology, or related field.

+ Must have extensive quality leadership experience at Management level with an excellent working knowledge of GMP and ISO regulations and accreditation process.

+ Must have experience in the management and oversight of the Quality Management System (QMS) specifically functioning within the GMP space.

+ Must have strategic development and leadership experience with policies and training for technical and operational staff.

+ Be proficient in the ISO / IEC 17025, USDA, 21 FDA CFR & CFR part 11 guide for testing laboratories.

+ Excellent written and verbal communication skills

+ Laboratory / technical auditing experience.

+ Hands on experience in a microbiological and chemical testing environment

+ 3-5 years experience in a commercial testing laboratory or equivalent. combination of education and experience.

+ Knowledge of Lean Six Sigma or similar processes aimed at process efficiencies.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-05-11 Expires: 2022-06-11

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Quality Assurance Director

Kelly Services
Fresno, CA 93744

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