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25 days old

Quality Assurance Manager - Irvine, CA

Kelly Services
Tustin, CA 92781
**Quality Assurance Manager - Irvine, CA**


**Summary/Objective:**


The QA Manager manages the Quality Operations team responsible for lot disposition, labeling, and batch production record issuance. Interacts with clients to resolve discrepancies and observations with regards to the Batch History Record. Develops solutions to Quality issues, following CGMP regulations and company guidelines. Develops and evaluates personnel to ensure the efficient and compliant operation of the Quality Operations group. Performs assigned tasks and work to achieve company goals and department objectives by following policies and procedures.


**Essential Functions:**


+ Manages routine operations and assigns tasks/new projects to Sr. Quality Specialists/Quality Specialists/Associate Specialists/ QA Clerks.

+ Dispositions Drug Substance lots and formulations.

+ Reviews Manufacturing Batch Production Records and supporting documentation in association with Batch History Records.

+ Reviews and issues Batch Production Records, labels, and shipping documentation.

+ Reviews test documentation from Microbiology and Analytical Chemistry groups.

+ Troubleshoots and initiates the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.

+ Serves as a Quality representative on cross-functional and multi-site teams.

+ Maintains a state of inspection readiness.

+ Authors, gains approval, and implements Quality Standard Operating Procedures and Quality Standard Records used in GMP systems and applications.

+ Identifies, designs, and implements process and system improvements.

+ Interacts with clients to address observations.

+ Serves as Quality subject matter expert (SME) in support of department functions.

+ Reviews, provides technical assessment, and approves controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product as needed.

+ Interacts with interdepartmental contacts on discrepancy assessment, resolution and quality approval as assigned.

+ Provide Quality oversight to internal and external customers.

+ Generates departmental performance metrics for review by management as assigned.


**Supervisory Responsibilities:**


+ Directs activities of functional areas for direct reports.


**Required Education and Experience:**


+ B.A. or B.S. degree (preferably in Life Science) and at least 5-7 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

+ Sound knowledge of CGMPs or equivalent regulations.

+ Ability to interpret and relate Quality standards for implementation and review.

+ Ability to make sound decisions about scheduling, allocation of resources and managing priorities.

+ Must be able to interpret Quality standards for implementation.

+ Ability to communicate clearly and professionally both in writing and verbally.

+ Flexibility in problem solving, providing direction and work hours to meet business objectives.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-19 Expires: 2021-06-19

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Quality Assurance Manager - Irvine, CA

Kelly Services
Tustin, CA 92781

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