Quality Assurance Specialist II

Catalent • San Diego, CA

1d • Onsite

About The Position

Quality Assurance Specialist II 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 pre-formulation 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 Quality Assurance Specialist II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.

Requirements

• High School Diploma or GED required.
• High School Diploma with 10+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• BS with 7+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• MS with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

Nice To Haves

• Bachelors or Master’s degree in a scientific discipline preferred.
• JD Edwards or comparable ERP systems preferred.

Responsibilities

• Performs pre and post execution batch record review.
• Authoring/Updating documents related to Material Management Quality Control, Material Management Quality Assurance, Batch Records, Compliance, and Validation Systems.
• Participates in Investigations and deviation writing.
• Support client communications.
• Reviewing /approving change controls and change actions
• Adhere to GMP standards routinely with limited errors and limited guidance
• 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: Mid Level
• Education Level: High school or GED