Title: QA RA Compliance Specialist (14692991)

Location: Petersburg, FL 33716

Pay: $30/hr with benefits

Duration: 06 months with high possibility of extension

Job Summary:

The Regulatory Affairs Specialist will coordinate, track, and manage change controls, ensuring compliance with regulatory requirements and internal procedures. The role involves regulatory submissions, impact assessments, quality assurance activities, and collaboration with internal teams and customers to uphold product and process standards.

Key Responsibilities:

• Coordinate, track, and trend change controls for the facility, ensuring compliance and completion of required actions.
• Provide initial regulatory impact assessments for change controls.
• Liaise with customers to address and satisfy regulatory requirements.
• Prepare and submit regulatory submissions, including A/NDA submissions, drug master files, site master files, licenses, permits, and registrations in compliance with FDA and state regulations (especially Florida).
• Ensure timely preparation and submission of federal, state, and local permits.
• Support registration activities by gathering required information from customers.
• Assist in preparing and reviewing standard operating procedures (SOPs) related to regulatory functions.
• Participate in regulatory and health authority audits, collecting and providing information as required.
• Collaborate with Subject Matter Experts (SMEs) and management to resolve quality issues, including investigating deviations and initiating corrective actions.
• Prepare Annual Product Reviews (APRs) in line with site procedures and timelines.
• Develop complaint investigation reports, conduct root cause analysis, and recommend corrective actions to prevent recurrence.
• Author quality system documents as assigned by QA management.
• Support high-performance objectives, including driving cGMP compliance, mentoring team members, and participating in internal assessments and CAPA reviews.
• Assist with special projects and other company/departmental objectives as directed.

Qualifications:

Education and Experience:

• Bachelor’s degree in Science (Chemistry, Microbiology, Biology, or related field).
• Minimum of 3 years of experience in the pharmaceutical manufacturing industry.
• Strong background in change control processes and management.
• Experience in investigation writing, root cause analysis, and report preparation (PathWise Certification preferred).

Knowledge and Skills:

• In-depth knowledge of US regulatory applications, cGMPs, and FDA guidance.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Access).
• Strong organizational skills and attention to detail.
• Excellent oral and written communication skills.
• Motivated, team-oriented self-starter with a strong quality work ethic.
• Proven ability to multitask and manage responsibilities diplomatically.
• Familiarity with OSHA regulations and cGMPs.

Additional Requirements:

• Participation in compliance meetings, training facilitation, and supporting internal reviews as needed.

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