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29 days old

Biotech Quality Assurance Specialist- Tustin, CA

Kelly Services
Tustin, CA 92781
**Quality Assurance Specialist**


**Location: Tustin, CA**


Salary: $65-80k Depending on Experience; Limited relocation assistance available for the right candidate


**Direct Hire with companies benefits including Medical, Dental, Vision, generous PTO, 401km as well as Pet Savings Program**


**Schedule:** Sunday-Wednesday OR Wednesday- Saturday 7am-6pm


+ **Training schedule:** Monday-Friday 9/8 am-5/6 pm


**Kelly Services has a great Direct Hire (perm) opportunity working as a Quality Assurance Specialist** for a contract development and manufacturing organization ("CDMO"). This team is focused on development and CGMP manufacturing of biopharmaceuticals products including monoclonal antibodies, enzymes, and recombinant proteins.


**Essential Duties and Responsibilities:**


+ Review of batch production records and quality investigations

+ Review of Manufacturing forms and paperwork in association with Batch Production Records

+ Advise production on proper documentation requirements as needed

+ Initiate deviations, assist in area investigations, and review of discrepancy reports

+ Maintain a state of inspection readiness

+ Maintain company quality and safety standards

+ 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

+ Identify and recommend solutions to potential procedure, process and system gaps

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

+ Represent Quality Assurance on multi-disciplinary project teams

+ Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs

+ Perform tasks as requested by Management to support Quality oversight activities


**Required Qualifications:**


+ B.A. or B.S. degree (preferably in Life Science) and at least 2-4 years of experience in the pharmaceutical, biopharmaceutical or related industry

+ Sound knowledge of cGMPs or equivalent regulations

+ Experience in Batch Record Review

+ Ability to make sound compliance-related decisions with minimal supervision

+ Must have strong attention to detail

+ Strong communication (written and verbal) and organizational skills

+ Strong problem solving and teamwork skills


**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: 2021-09-24 Expires: 2021-10-25

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Biotech Quality Assurance Specialist- Tustin, CA

Kelly Services
Tustin, CA 92781

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