Senior Quality Assurance Specialist

Catalent • San Diego, CA

399d • $87,000 - $95,000

About The Position

The Senior Quality Assurance Specialist at Catalent Pharma Solutions in San Diego plays a crucial role in ensuring compliance with regulatory standards in the pharmaceutical industry. This position involves providing regulatory expertise in the investigation and deviation management process, ensuring that products are manufactured, packaged, and tested according to FDA guidelines and internal SOPs. The role requires collaboration with internal and external clients, as well as mentoring and training other team members. The position is full-time, Monday to Friday, with a potential training period in Kansas City, MO.

Requirements

• Bachelor's or Master's degree in a scientific discipline.
• Minimum of five years of applicable pharmaceutical GMP QA knowledge.
• Experience in investigations/deviations, QC lab, manufacturing, and batch record review.
• Six Sigma or ASQ certification preferred.
• Ability to follow and provide various instructions in written, oral, or diagram form.
• Proactive problem-solving skills at individual and team levels.
• Mathematical and scientific reasoning ability to identify data issues.
• Collaboration and leadership capabilities in a matrix environment.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience in a GMP QA setting is favorable.

Responsibilities

• Inspect incoming materials for GMP production and assist with packaging floor activities.
• Perform production batch record review/approval and issue Certificates of Compliance (COCs).
• Revise SOPs, Work Instructions, and Forms related to quality assurance.
• Conduct quality verification of labeling activities and manage document issuance and archival.
• Review and track investigations, deviations, and corrective actions for compliance.
• Ensure products meet FDA guidelines and internal SOPs during manufacturing and testing.
• Participate in quality programs to maintain established standards and agency guidelines.
• Gather data and ensure timely compliance in investigations and deviations.
• Follow Good Documentation Practices and cGMPs for compliance with FDA and MHRA guidelines.
• Respond and interact professionally with internal and external clients.
• Assist in executing efficiency improvement projects and mentor others.

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 plus 10 paid holidays.
• Tuition Reimbursement for further education.
• On-site fitness center and wellness programs.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Employee activities and company-sponsored events.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees