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Qa Ra Compliance Specialist

10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills:

Position: QA RA Compliance Specialist
Location: Saint Petersburg, FL 33716
Employment Type: Contract
Job Category: Regulatory Affairs
Job Number: 617195
Is Job Remote?: No
Compensation: $20-30/hr (depending on experience)


Job Overview

Planet Pharma is seeking a QA RA Compliance Specialist to join a pharmaceutical manufacturing team in Saint Petersburg, FL. This role involves managing change controls, regulatory submissions, and assisting with audits and investigations to ensure compliance with FDA and state requirements. You will collaborate with internal teams and customers, contributing to product quality and ensuring that the necessary documentation and regulatory submissions are completed.

Key Responsibilities

  • Coordinate, track, and trend change controls for the facility, ensuring implementation meets requirements.
  • Provide regulatory impact assessments for all change controls.
  • Prepare and submit A/NDA submissions, drug master files, and licenses, ensuring FDA and state requirements are met.
  • Submit federal, state, and local permits in a timely manner.
  • Collaborate with customers to gather information for registration activities.
  • Assist in preparing, reviewing, and approving SOPs related to the job function.
  • Support audits and collect information as requested.
  • Collaborate with teams to resolve product quality issues and initiate CAPA processes.
  • Prepare Annual Product Reviews (APRs) and complaint investigation reports.
  • Assist in compliance tasks, including mentoring and training staff, and facilitating compliance meetings.

Qualifications

  • Bachelor’s Degree in Science (Chemistry, Microbiology, Biology) or related field.
  • Minimum of 3 years of experience in pharmaceutical manufacturing.
  • Strong background in managing change controls and investigations.
  • Prior experience with regulatory affairs, quality control, or assurance required.
  • Knowledge of US regulations, cGMPs, FDA Guidance, and OSHA regulations.
  • Strong organizational, communication, and report writing skills.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access).
  • PathWise Certification preferred.

Additional Information

Planet Pharma is an equal opportunity employer, committed to diversity, equity, and inclusion. Candidates from all backgrounds are encouraged to apply.