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QA RA Compliance Specialist

Job Opportunity: QA/RA Compliance Specialist (Biotech)

Location: Florida, USA (Open to U.S. citizens, preferably local residents)

Mode: Onsite

Positions Available: 1

Duration: Six months with possible extension

Shift: Monday to Friday, 8:00 AM - 5:00 PM or 9:00 AM - 6:00 PM


ProQuality Network is seeking a QA/RA Compliance Specialist to support one of our clients in the biotech industry. This is a contract position offering an exciting opportunity to contribute to critical quality and regulatory functions in a high-performance environment.


Key Responsibilities:

  • Coordinate, track, and trend change controls issued for the facility.
  • Ensure change controls meet initial requirements for implementation and review completed change controls for action completion.
  • Provide initial regulatory impact assessments on change controls as required.
  • Liaise with customers to satisfy regulatory and quality requirements.
  • Prepare and submit regulatory documentation, including:
  • A/NDA submissions (initial, amendments, supplements, annual reports, and 15-day alert reports).
  • Drug master files, plant/site master files, licenses, permits, and registrations to meet FDA and state requirements (especially Florida).
  • Ensure timely submission of federal, state, and local permits.
  • Collect and compile data for registration activities in collaboration with customers.
  • Assist in preparing and reviewing SOPs related to the regulatory function.
  • Support regulatory/health authority audits by collecting and providing requested information.
  • Collaborate with Subject Matter Experts (SMEs), management, and supervisors to resolve product quality issues through investigations, CAPA initiation, and resolution.
  • Prepare Annual Product Reviews (APRs) in accordance with site procedures and timelines.
  • Prepare complaint investigation reports, conduct root cause analysis, verify batch impact assessments, and recommend corrective actions.
  • Author and review various quality system documents as assigned by QA management.
  • Support site management in enforcing cGMP compliance, mentoring staff, and conducting training sessions.
  • Participate in Internal Assessments, Compliance and CAPA Review Board meetings, and special projects.


Education and Experience Requirements:

  • Bachelor’s degree in Science or a related field (Chemistry, Microbiology, or Biology preferred).
  • Minimum of 3 years of experience in the pharmaceutical manufacturing industry.
  • Strong background in managing change control processes and regulatory affairs.
  • Experience in investigation writing, root cause analysis, and preparing annual product reviews (PathWise Certification preferred).


Knowledge and Skills Requirements:

  • Thorough knowledge of cGMPs, FDA regulations, and guidance documents.
  • Prior experience in quality assurance, quality control, or regulatory affairs.
  • Excellent organization skills with extreme attention to detail.
  • Strong oral and written communication skills.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Access).
  • Motivated, self-starter, and team player with strong quality work ethic.
  • Ability to multitask, resolve conflicts diplomatically, and manage time effectively.


📢 Ready to make a difference?

Join ProQuality Network and take the next step in your career. Apply today inside the job description with an updated resume and become part of a team dedicated to excellence!



Thank you. We will be in contact soon.

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