Role: QA / Regulatory Affairs Specialist
Location: St. Petersburg, FL
Duration: 06 months with possible extension
What You'll Do:
- Manage and review Change Controls and ensure proper documentation.
- Perform regulatory impact assessments and support FDA/state submissions.
- Prepare and submit A/NDA, DMFs, permits, and annual reports.
- Support audits, CAPAs, complaint investigations, and Annual Product Reviews.
- Collaborate with teams on quality events, SOPs, and process improvements.
- Participate in training, compliance reviews, and internal assessments.
What we are looking for:
- Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology);
- A minimum of 3 years related experience in the pharmaceutical manufacturing industry.
- Strong background working with Change Controls and management of change control processes.
- Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred).
- PathWise Certification preferred.
- Prior regulatory affairs, quality control or quality assurance experience is a must.
- Working knowledge of US application regulations and cGMPs, and FDA Guidance for both.
- Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
- Working knowledge of cGMPs and/or OSHA regulations required.