Quality Assurance Associate

Overview Catalent’s flagship Softgel development and manufacturing facility in St. Petersburg, FL, produces 18 billion capsules per year. This entry‑level role offers competitive pay, day‑one benefits and career growth in a state‑of‑the‑art, turn‑key facility. Role The Quality Assurance Associate supports QA activities in a GMP pharmaceutical manufacturing environment. Shift: Monday through Friday, 8 a.m. to 5 p.m. 100% onsite and located in St. Petersburg. Responsibilities Provide routine QA support to manufacturing operations by monitoring activities on the floor and ensuring compliance with cGMPs and approved SOPs. Assist in documenting, reviewing, and following up on manufacturing events, deviations and discrepancies under guidance from senior QA staff. 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. Provide real‑time guidance to Operations during production events as defined by SOPs; escalates issues appropriately to senior QA or QA management. Perform other duties as required to support high performance at Catalent Pharma Solutions. Qualifications Bachelor’s degree in Science or related field (Biology, Chemistry, Microbiology) with little or no prior GMP manufacturing experience, OR high school diploma with at least three years of experience in regulated manufacturing environments. Ability to work effectively under pressure to meet deadlines. Physical ability to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Access to manufacturing floor and office staff and use of required office equipment. Vision requirements include reading written documents and frequent use of a computer monitor. Preferred Skills and Background 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 (Word, Excel, PowerPoint). Team‑oriented mindset with ability to collaborate with Operations, QC, Engineering and QA personnel. Benefits Competitive paid time off plus eight paid holidays. Medical, dental and vision benefits effective from day one. Tuition reimbursement. Well‑being programs and employee discounts. EEO and Accommodation Statement Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email your request to View email address on click.appcast.io, including the job number, title and location. #J-18808-Ljbffr