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29 days old

Sr. Quality Systems Specialist - Irvine, CA

Kelly Services
Tustin, CA 92781
**Sr. Quality Systems Specialist**


**Summary/Objective:**


The roles of the Specialist and Sr. Specialist, Quality Systems, are to provide technical review of Quality Management System discrepancy reports and CAPAs. Participate in the generation and revision of controlled and project documents. Perform assigned tasks and work to achieve company goals and department objectives.


**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.

+ Author, review, edit, and approve CAPA records; ensure CAPA records meet procedural and regulatory requirements.

+ Author, review, edit, and approve controlled documents including, but not limited to, standard operating procedure (SOPs), forms, and BPRs.

+ Participate in the generation and revision of controlled and project documents; author, review, edit, and approve controlled documents (including procedures, methods, and forms related to quality systems and to manufacture and testing of product) and project documents (including protocols and reports related to development, validation, and stability).

+ Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.

+ Maintain a state of inspection readiness; participate in inspection preparation activities.

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

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

+ Independently manage competing priorities with limited instruction.

+ Follow company policies and procedures.

+ Perform other duties as assigned by Management.

+ Position Type/Expected Hours of Work: This role is a full-time position. Days and hours of work are Monday through Friday, unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime (extended hours) and/or weekends when necessary.


**Required Education and Experience:**


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

+ Minimum of 2 - 4 (4 - 6 for Sr. Specialist) years of experience in the biopharmaceutical industry (preferably with biologics).

+ Knowledge of cGMPs or equivalent regulations.

+ Ability to interpret Quality standards for implementation.

+ Skills to independently evaluate situations and propose potential solutions.

+ Able to interpret Quality standards for implementation.

+ Excellent technical writing and editing skills.

+ Progressive experience in deviation records.

+ Experience in use of quality systems software (quality management systems and/or electronic document management systems).


**_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: 2021-08-18 Expires: 2021-09-18

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Sr. Quality Systems Specialist - Irvine, CA

Kelly Services
Tustin, CA 92781

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