Catalent
Quality Assurance Specialist
We are looking to hire a
Quality Assurance Specialist
to manage and document events/discrepancies associated with product or process, investigate customer complaints, prepare annual product reviews, and track CAPA program compliance.
Position Summary Location: St. Petersburg, FL (100% on site). This role follows a rotating 2‑2‑3 schedule from 7 pm to 7 am. St. Petersburg is our primary soft‑gel development and manufacturing facility, producing 18 billion capsules per year.
Responsibilities
Collaborate with Operations, QC, and QA to resolve product quality issues, investigate non‑conformance, and drive joint resolutions.
Provide guidance and action plans during production events per SOP and lead investigations of non‑compliant issues.
Prepare complaint investigation reports, verify scope, conduct root‑cause analysis, assess batch impact, and recommend corrective actions for prevention.
Write and author other quality system documents as directed.
Liaise with customers to ensure requirements are satisfied.
Facilitate CAPA commitments, including initiation, tracking, trending, and effectiveness checks.
Prepare annual product reports and ensure timely closure.
Qualifications
Bachelor’s Degree in Chemistry, Microbiology, Biology, or a related science field.
Minimum three years of QA experience in pharmaceutical manufacturing.
Experience in investigation writing, root‑cause analysis, and report writing; experience preparing annual product reviews preferred.
Knowledge of cGMPs and/or OSHA regulations.
Ability to work under pressure and meet deadlines; must tolerate regular sitting, standing, walking, and occasional lifting to 15 lb (no lift > 44.09 lb without assistance).
Proficiency with computer monitoring, reading documents, and office equipment.
Benefits
Competitive medical benefits and 401(k).
152 hours of PTO + 8 paid holidays.
Dynamic, fast‑paced work environment.
Opportunity to contribute to continuous improvement processes.
About Catalent Catalent is a global drug development and delivery leader. We help bring over 7,000 life‑saving and life‑enhancing products to patients worldwide, producing more than 70 billion doses per year. Our employees work directly with pharma, biopharma, and consumer health companies, advancing new medicines from early development through clinical trials to market.
Equal Opportunity and Accommodation 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 submit your request along with the job number, title, and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability.
Agency and Security Notice Catalent Pharma Solutions does not accept unsolicited resumes from agencies or search firms. Resumes submitted by an agency without a written and signed agreement will become the sole property of Catalent and will not be remunerated if a candidate is hired.
Catalent never asks candidates to provide payment, bank details, photocopies of identification, social security number, or other highly sensitive information during the offer process. If you receive such a request, DO NOT respond—forward it to spam@catalent.com for investigation.
California job seekers should review the California Job Applicant Notice.
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Quality Assurance Specialist
to manage and document events/discrepancies associated with product or process, investigate customer complaints, prepare annual product reviews, and track CAPA program compliance.
Position Summary Location: St. Petersburg, FL (100% on site). This role follows a rotating 2‑2‑3 schedule from 7 pm to 7 am. St. Petersburg is our primary soft‑gel development and manufacturing facility, producing 18 billion capsules per year.
Responsibilities
Collaborate with Operations, QC, and QA to resolve product quality issues, investigate non‑conformance, and drive joint resolutions.
Provide guidance and action plans during production events per SOP and lead investigations of non‑compliant issues.
Prepare complaint investigation reports, verify scope, conduct root‑cause analysis, assess batch impact, and recommend corrective actions for prevention.
Write and author other quality system documents as directed.
Liaise with customers to ensure requirements are satisfied.
Facilitate CAPA commitments, including initiation, tracking, trending, and effectiveness checks.
Prepare annual product reports and ensure timely closure.
Qualifications
Bachelor’s Degree in Chemistry, Microbiology, Biology, or a related science field.
Minimum three years of QA experience in pharmaceutical manufacturing.
Experience in investigation writing, root‑cause analysis, and report writing; experience preparing annual product reviews preferred.
Knowledge of cGMPs and/or OSHA regulations.
Ability to work under pressure and meet deadlines; must tolerate regular sitting, standing, walking, and occasional lifting to 15 lb (no lift > 44.09 lb without assistance).
Proficiency with computer monitoring, reading documents, and office equipment.
Benefits
Competitive medical benefits and 401(k).
152 hours of PTO + 8 paid holidays.
Dynamic, fast‑paced work environment.
Opportunity to contribute to continuous improvement processes.
About Catalent Catalent is a global drug development and delivery leader. We help bring over 7,000 life‑saving and life‑enhancing products to patients worldwide, producing more than 70 billion doses per year. Our employees work directly with pharma, biopharma, and consumer health companies, advancing new medicines from early development through clinical trials to market.
Equal Opportunity and Accommodation 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 submit your request along with the job number, title, and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability.
Agency and Security Notice Catalent Pharma Solutions does not accept unsolicited resumes from agencies or search firms. Resumes submitted by an agency without a written and signed agreement will become the sole property of Catalent and will not be remunerated if a candidate is hired.
Catalent never asks candidates to provide payment, bank details, photocopies of identification, social security number, or other highly sensitive information during the offer process. If you receive such a request, DO NOT respond—forward it to spam@catalent.com for investigation.
California job seekers should review the California Job Applicant Notice.
#J-18808-Ljbffr