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24 days old

Biopharma Quality Assurance Specialist (Direct Hire!) College Station, TX

Kelly Services
College Station, TX 77840
Kelly Science and Clinical is currently seeking candidates for a Quality Assurance Specialist position for a Biopharma company in College Station, TX. The overall responsibility of this role is to provide quality oversight to the disposition of all materials manufactured by the company.


**Responsibilities:**


+ Represent the QA department in internal and external meetings related to batch release.

+ Assist with identifying compliance gaps during internal and external site audits.

+ Provide Quality oversight to Deviations, Change Controls, CAPAs, New Product Introductions (NPIs), Quality Control Assays (QCAs), and Batch Records (BRs).

+ Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).

+ Support investigations into quality system issues.

+ Maintaining a batch release tracking system.

+ Close all required deliverables to support the disposition of batches.

+ Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch release process.

+ Track and trend metrics for QA on Deviations, CAPAs, and Change Controls on a monthly basis.

+ Mentor and train less experienced staff members.


**Qualifications:**


+ Bachelors degree in the sciences, preferably in Microbiology, Biochemistry, Biotechnology, or related.

+ 3-5 years of cGMP experience in QA or Manufacturing with an emphasis in Cell and Gene Therapy.

+ Must possess GMP compliance knowledge including CFR, PICS, and EU guidelines to Good Manufacturing Practices.

+ Ability to become gown qualified.


**Job Details**


+ Job Type: Direct Hire

+ Work Schedule: Monday-Friday, 8:00am-5:00pm

+ Relocation/Sign on Bonus provided


**If you meet the above qualifications, please submit your resume for immediate consideration for this high priority role!**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-05 Expires: 2022-10-06

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Biopharma Quality Assurance Specialist (Direct Hire!) College Station, TX

Kelly Services
College Station, TX 77840

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