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19 days old

Sr. Quality Assurance Associate, Biologics â?? San Diego, CA

Kelly Services
San Diego, CA 92108
**Sr. Quality Assurance Associate, Biologics San Diego, CA**



**Shift:** M-F; 8am 5pm with occasional weekends when needed



**Position Type:** Direct Hire



**Typical Duties Include**




+ All duties are performed independently with minimal supervision and oversight. Incumbent is considered expert in the document review process.

+ Perform review of production batch records and test records for intermediates, drug substance and drug product.

+ Perform review of stability data and testing records for drug substance and drug product.

+ Perform review of facility cleaning records and other GMP records related to facility, equipment maintenance and calibration program.

+ Provide expert support in the disposition of Drug Substance and Drug Product lot. Generate Quality Assurance (QA) disposition forms and Certificate of Analyses.

+ Perform review of analytical method qualification reports and associated test data.

+ Provide support in disposition of raw material used in cGMP manufacturing.

+ Subject Matter Expert (SME) in support of internal audits and reviews.

+ Analyzes data and documentation to support recommendation for batch disposition.

+ Provide expert support for the Vendor Qualification Program with respect to components and excipients used for drug product manufacture.

+ Follow SOPs and documents to work in accordance with cGMPs.

+ Write and revise SOPs, qualification protocols, specifications, test methods and reports.

+ Train employees on GMP and CFR regulations, and specific procedures.

+ Initiates and participates in the investigations into environmental monitoring excursions to assess any potential impact to product.



**General Responsibilities:**




+ Complies with policies and procedures.

+ Adheres to quality standards set by regulations and policies, procedures and mission.

+ Communicates effectively with supervisors, colleagues, customers and subordinates.

+ Ability to participate effectively as a team player in all aspects of business.

+ Travels as needed to attend professional conferences, and train on new technologies.



**Qualifications/Skills Required:**




+ BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)

+ Five (5) to eight (8) years of GMP Quality Assurance experience, preferably in biologics manufacturing operations.

+ Knowledge of cGMP, 21CFR, USP and other applicable regulations, standards and guidance.

+ Ability to deploy quality systems within the biologics industry.

+ Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.

+ Skill in writing to effectively communicate complex ideas and concepts.

+ Knowledge of contract manufacturing processes and relevant quality assurance programs.

+ Knowledge of cGMP auditing practices.

+ Knowledge of raw materials, production processes, quality control, costs and other techniques for maximizing the effective manufacture and distribution of goods.

+ Skill to accurately and precisely document and record laboratory activities, results and conclusions.

+ Ability to work well under pressure, multi-task, be organized and have effective communication skills.

+ Ability to read and interpret documents.

+ Skill to write and modify documents, to include Standard Operating Procedures (SOPs).

+ Ability to review and understand test data.



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1






**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-07-20 Expires: 2020-08-20

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Sr. Quality Assurance Associate, Biologics â?? San Diego, CA

Kelly Services
San Diego, CA 92108

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