Quality Assurance Associate

Catalent • Saint Petersburg, FL

4d • Onsite

About The Position

Join Catalent’s flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. This role will provide hands-on quality support on the manufacturing floor by assisting with documentation review, investigation activities, ensure compliance with GMPs, and Standard operating Procedures. The Quality Assurance Associate is an entry-level role designed to support Quality Assurance activities in a GMP pharmaceutical manufacturing environment.

Requirements

• Bachelor’s degree in Science or a related field (e.g., Biology, Chemistry, Microbiology) with little or no prior GMP manufacturing experience, OR High school diploma or equivalent with at least three years of experience in pharmaceutical, medical device, or other regulated manufacturing environments.
• Ability to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Specific vision requirements include reading of written documents and frequent use of computer monitor.

Nice To Haves

• Basic understanding of cGMP principles or willingness to learn.
• Ability to follow procedures and work effectively in a regulated environment.
• Good written and verbal communication skills (ESL-friendly environment).
• Strong organizational skills and ability to manage multiple tasks under supervision.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Team-oriented mindset with the ability to collaborate with Operations, QC, Engineering, and QA personnel.

Responsibilities

• Provide routine QA support to manufacturing operations by monitoring activities on the manufacturing floor and ensuring compliance with cGMPs and approved SOPs.
• Assist in the documentation, review, and follow-up of manufacturing events, deviations, and discrepancies under guidance from senior QA staff or QA management.
• Support investigation activities by gathering documentation, assisting with fact-finding, and helping draft investigation reports related to process, equipment, or documentation events.
• Perform work order evaluations and quality impact assessments related to equipment breakdowns, maintenance activities, and equipment-related events, in accordance with site procedures.
• Support batch record review activities to ensure documentation accuracy, completeness, and compliance with Good Documentation Practices (GDP).
• Provide real-time guidance to Operations during production events as defined by SOPs and escalate issues appropriately to senior QA or QA management.
• Perform other duties as required to support high performance at Catalent Pharma Solutions.

Benefits

• Competitive Paid Time Off plus 8 paid holidays
• Medical, dental, and vision benefits effective from day one
• Tuition reimbursement to support your educational goals
• Engaging site-based activities such as NCAA Basketball Brackets, Golf Scrambles, and Onsite Pet Adoption Events
• Employee Resource Groups promoting diversity and inclusion
• Community engagement initiatives including Adopt-a-Highway clean-up
• Defined career path with annual performance reviews and growth opportunities
• WellHub program for physical and mental wellness
• Exclusive discounts through Perkspot from over 900 merchants

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level