QA Associate I, Manufacturing

Catalent • San Diego, CA

6d • Onsite

About The Position

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.

Requirements

• High school diploma required
• 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.

Nice To Haves

• BS/BA degree desirable

Responsibilities

• 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.

Benefits

• 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.
• Tuition Reimbursement
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED