Catalent Pharma Solutions Quality Assurance Associate II in San Diego, California

Job Description

Catalent San Diego is looking to hire a QA Associate II (Manufacturing) who will function as a key player, within the QA department, while reporting to the QA Manager, Manufacturing. In this role, the QA Associate II will primarily focus on reviewing related documents and supporting cleaning verification and manufacturing. The individual will also be responsible for evaluating the compliance of manufacturing documents such as equipment calibration and qualification records, equipment change requests, raw material specifications, equipment cleaning packets, etc. with minimal supervision.

The Role (daily responsibilities)

  • Performance of general QA activities such as line clearances, internal audits, issuing documents, change control and investigation numbers, etc.

  • Review and approve equipment calibration or qualification reports.

  • Support Equipment and Cleaning Validation including review and approval of Validation of equipment documentation IQ, OQ, and PQs and also review cleaning verification and releasing assets for production.

  • Review and release of product labels and annual retain inspections.

  • Review and release raw materials for production.

  • Review and approve controlled documents such as SOPs, protocols, validations and change requests. Review and approval of variance documentation under supervision.

  • Supporting role in client or external audits.

The Candidate (requirements)

  • 2+ years of applicable cGMP, QA, Validation or related Manufacturing industry experience required. Strong background in review of Cleaning Validation related documents highly desired. Experience with HPLC in a lab setting would also be preferred.

  • Bachelors of Science degree, from an accredited university, is required.

  • Must demonstrate excellent communication, critical thinking, and organizational skills.

  • Familiarity with applicable cGMP regulations and possess the ability to make decisions based those requirements.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

  • Defined career path and annual performance review and feedback process. Potential for career growth within an expanding team available!

  • We provide a generous benefits package (include healthcare insurance, 401k, etc.), on-site gym and fitness programs, team sports, activities and competitive compensation.

  • Generous paid time off (PTO) 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.

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, protected veteran status, sexual orientation or gender identity. 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.