Senior Quality Specialist

Catalent•San Diego, CA

1d•$92,000 - $102,000•Onsite

About The Position

Senior Quality Assurance Specialist 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 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 Senior Quality Assurance Specialist supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Senior QA Specialist provides regulatory expertise to the investigation and deviation management process and participates in and maintains site audit readiness by working closely with all departments within the business unit.

Requirements

HS Diploma or GED required. Bachelor's or Master's degree in a scientific field preferred.
10+ years of Quality Assurance experience in a GMP manufacturing environment or equivalent experience required.
Use existing procedures and established literature to solve routine and non-routine problems
Utilize all elements of the quality system to identify, classify and control the status of finished products produced
Ability to identify and provide guidance/mitigation for aberrant data and potential quality/compliance concerns escalating to management
Strong 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.

Nice To Haves

Six Sigma or ASQ certification preferred.

Responsibilities

Performs batch record review and acts as lead investigator for deviations and complaints.
Ensures that products are manufactured, packaged, tested and released according to applicable procedures.
Performs in-process audits, line clearance, verification of line clearance.
Performs label approval, print requests, label release.
Reviews and tracks investigations/ deviations and corrective actions.
Review and approval Data integrity requirements relating to validation and onboarding requirements for commercialization from clinical processes.
Other duties as assigned.

Benefits

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.