Catalent San Diego is hiring for a Quality Assurance Associate II who will focus on Analytical Data Review. The QA Associate II must be familiar with applicable cGMP regulations and systems and have the ability to make decisions based those requirements. This individual will be responsible for evaluating the compliance of manufacturing and analytical documents such as test methods, batch records, stability and release data, protocols, SOPs, etc. with minimal supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. Qualified candidate will be hired at the appropriate level commensurate with education and years of required relevant experience.
The Role (daily responsibilities)
Review of analytical release and stability data.
Review and approval of controlled documents such as SOPs, CPPs, protocols, test methods, and specifications.
Review and approval of OOS and Deviation documentation.
Performance of internal and external audits.
Lead role in manufacturing activities including but not limited to line clearance, label quarantine/release, cleaning verification review, and raw material release data review.
Lead or supporting role in client audits.
The Candidate (requirements)
Minimum of 2 years of applicable cGMP industry experience. Analytical laboratory, QC laboratory, Manufacturing, QA experience may be considered applicable. A candidate must have relevant lab experience within either the pharmaceutical or biopharmaceutical industry to qualify.
Requires familiarity with HPLC data interpretation.
BS science degree, preferably in Chemistry or Biochemistry, from an accredited university.
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
Medical, Dental, Vision and 401k are all offered from Day One of employment
Generous paid time off and holidays
About Catalent San Diego
Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.
About Catalent Pharma Solutions
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied.
Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.