Quality Assurance Associate

About Site 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. Position Summary The Quality Assurance Associate is an entry-level role designed to support Quality Assurance activities in a GMP pharmaceutical manufacturing environment. Shift: Monday - Friday 8 am - 5 pm Location: St. Petersburg 100% Onsite The Role 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. The Candidate Minimum 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. Preferred Skills & 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 applications (Word, Excel, PowerPoint). Team-oriented mindset with the ability to collaborate with Operations, QC, Engineering, and QA personnel. Why You Should Join Catalent Positive and fast-paced working environment focused on continuous improvement and innovation 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 Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. 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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .