Quality Assurance Associate

About the role

Catalent’s flagship Softgel development and manufacturing facility in St. Petersburg, FL, with a capacity of 18 billion capsules per year, is seeking a Quality Assurance Associate. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility.

Responsibilities

• Monitor activities on the manufacturing floor and ensure compliance with cGMPs and approved SOPs.
• Aid 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.
• Evaluate work orders and perform quality impact assessments related to equipment breakdowns, maintenance activities, and equipment-related events, in accordance with site procedures.
• Review batch records 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.

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.
• Basic understanding of cGMP principles or willingness to learn.
• 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.

Qualifications

• Minimum requirements include a Bachelor’s degree in Science or a related field, or a High school diploma with at least three years of relevant experience.
• Must have the ability to work effectively under pressure to meet deadlines.
• Must have basic understanding of cGMP principles or willingness to learn.
• Must have good written and verbal communication skills (ESL-friendly environment).
• Must have strong organizational skills and ability to manage multiple tasks under supervision.
• Must be proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Must have a team-oriented mindset with the ability to collaborate with Operations, QC, Engineering, and QA personnel.

Skills

• 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.

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.

Pay

• Competitive pay offered based on qualifications and experience.

Schedule

• Monday - Friday 8 am - 5 pm.

Contact

• For more information about this opportunity, visit Catalent Careers.
• To apply, please send your resume to [email protected] with the job number, title, and location.

Equal Opportunity Employer

• Catalent is an Equal Opportunity Employer, including disability and veterans.

Important Security Notice

• Never provide any payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the application or hiring process.
• If you receive any such request, DO NOT respond— it is a fraudulent request.