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6 days old

Quality Systems Supervisor - Irvine, CA

Kelly Services
Tustin, CA 92781
**Quality Systems Supervisor - Irvine, CA**


**Summary/Objective:**


The role of the Supervisor, Quality Systems is to solve a variety of issues following cGMP regulations and company standards. This role performs assigned tasks and works to achieve company goals and department objectives by following policies and procedures.


**Essential Functions:**


+ Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.

+ Review testing documentation from the microbiology and chemistry groups.

+ Author, review, edit, and approve documents including, but not limited to, standard operating procedures (SOPs), batch production records (BPRs), protocols, reports, and forms.

+ Review and approve stability studies and documentation for drug substance, drug product and placebo.

+ Maintain a state of inspection readiness.

+ Collaborate with Management to establish and meet targets and timelines.

+ Independently manage competing priorities with limited instruction.

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

+ Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.

+ Identify, design, and implement process and system improvements.

+ Provide assistance to internal and external customers in support of departmental functions.

+ Participate in the design and implementation of department and cross-functional initiatives.

+ Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

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

+ Sign documents for activities as authorized and described by company policies, procedures and job descriptions.

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

+ Perform tasks as requested by Management to support Quality oversight activities. Technical Duties/Responsibilities:

+ Review and approve document revisions and updates (SOP, TM, Test Method forms).

+ Review, provide technical assessment and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.

+ Review and approve controlled documents relating to Quality involvement in product development studies as assigned.

+ Participate in inspection preparation activities.

+ Write and assist with quality system records such as deviation records. Ensure deviations are thoroughly identified, defined, and properly assessed.

+ Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.

+ Perform other duties as assigned.


**Required Education and Experience:**


+ B.A. or B.S. degree (preferably in Life Science)

+ At least 5 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

+ **Experienced with Deviation Records**

+ 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: 2021-09-10 Expires: 2021-10-11

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Quality Systems Supervisor - Irvine, CA

Kelly Services
Tustin, CA 92781

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