QA Associate I, Manufacturing

About this role

QA Associate I, Manufacturing

Position Summary: • Work Schedule: Monday-Friday, core hours 8am-4:30pm

• 100% on-site (San Diego)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic.  This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution.  Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.

The Manufacturing Quality Assurance (MQA) Associate I is responsible for a wide variety of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the development and manufacture of drug candidates. This will include documentation review and approval, dispositioning of product or its intermediates and supporting manufacturing operations.

The Role: • Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP regulations.

• Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents.

• Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records and review status.

• Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections. 

• Reviews and approves GMP product labels.

• Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs.

• Other duties as assigned.

The Candidate: • High school diploma required; BS/BA degree desirable

• Work experience in a GXP manufacturing environment or similar is preferred.

• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude.

Pay: • The anticipated salary range for this role in California is $60,000 to $70,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.  Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent: • Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.

• Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.

• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.  

• Several Employee Resource Groups focusing on Diversity and Inclusion.

• Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 

• 152 hours of PTO + 10 paid holidays.

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Catalent offers rewarding opportunities to further your career!   Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees 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. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.

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