QA Associate I, Manufacturing

About the role

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.

Responsibilities

• Reviews and disposes 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.
• Supports 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.
• Performs other duties as assigned.

Requirements

• 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.

Qualifications

• None specified.

Skills

• Detail-oriented.
• Organized.
• Independent work ability.
• Team player.

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.
• Positive and dynamic working environment.
• Opportunities for career growth.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Tuition Reimbursement.
• Wellness programs.
• Exclusive discounts through PerkSpot.

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.