Quality Assurance Specialist II

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.

The Role:

• 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.

The Candidate:

• High School Diploma or GED required. Bachelors or Master’s degree in a scientific discipline preferred.

• 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.

• JD Edwards or comparable ERP systems preferred.

• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

• Physical Requirements: Frequent standing, walking, and sitting required. Position occasionally requires lifting, pushing, and pulling of up to 35 lbs. Occasional kneeling and reaching required.

Pay:

• The anticipated salary range for this role in California is $85,000 to $89,000 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.