QA RA Compliance Specialist

Job Title: QA RA Compliance Specialist

Location: (St. Petersburg, FL)
Duration: Contract - 6 months with possible extension
Pay Range: $30.00/hr (W2)
Job ID: 372171
Worksite: Onsite
Schedule: Monday to Friday, 8:00 a.m. to 5:00 p.m. or 9:00 a.m. to 6:00 p.m.

About BCforward

BCforward is a leading global IT consulting and workforce solutions firm providing services and support to Fortune 500 and government clients. Founded in 1998, BCforward has grown with our customers needs into a full-service business solutions provider. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.

Job Description

We are seeking a QA RA Compliance Specialist to join our dynamic team. The ideal candidate will have strong experience in change control management, regulatory submissions, and quality systems and a proven ability to drive compliant outcomes across audits, investigations, and product quality initiatives.

Responsibilities:

• Coordinate, track, and trend facility change controls, ensuring initiation requirements are met and completed actions are verified.
• Provide initial regulatory impact assessments for change controls as required.
• Liaise with customers to ensure requirements are understood and satisfied.
• Prepare and submit A/NDA submissions (initial, amendments, supplements, annual reports, 15-day alert reports), drug master files, plant/site master files, licenses, permits, and registrations to meet FDA and State requirements, including Florida.
• Prepare and submit all federal, state, and local permits in a timely manner.
• Gather information from customers to support registration activities.
• Assist with drafting, reviewing, and approving SOPs related to regulatory functions under the direction of the Group Leader.
• Support regulatory and health authority audits by collecting requested information.
• Collaborate with SMEs and site leadership to resolve product quality issues, including investigations, CAPA initiation, and follow-up to resolution.
• Prepare Annual Product Reviews (APRs) per site procedures and timelines.
• Prepare complaint investigation reports, validate investigation scope and root cause analysis, assess batch impact, recommend corrective actions, and ensure on-time closure.
• Author additional quality system documents as assigned by QA management.
• Support cGMP compliance activities, mentor team members, participate in Internal Assessments, and facilitate compliance and CAPA Review Board meetings with follow-up actions and training.
• Assist with departmental objectives and special projects as directed by the Group Leader.

Required Skills & Qualifications:

• Bachelor's degree in a scientific discipline such as Chemistry, Microbiology, or Biology.
• Minimum 3 years of experience in pharmaceutical manufacturing.
• Proven experience with change controls and change control processes.
• Demonstrated investigation writing, root cause analysis, and report writing skills; APR experience preferred.
• Regulatory affairs, quality control, or quality assurance experience.
• Working knowledge of U.S. application regulations, cGMPs, and FDA guidance.
• Strong organization skills and attention to detail.
• Effective oral and written communication skills and teamwork ability.
• Ability to manage multiple priorities and apply diplomatic problem solving.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Access).
• Knowledge of OSHA requirements and cGMP regulations.

Preferred Skills:

• PathWise certification.
• Experience preparing Annual Product Reviews.

Why BCforward?

At BCforward, we believe in advancing lives and careers. When you join our team, you gain access to:

• Competitive compensation and benefits
• Opportunities for growth with global clients
• A supportive, inclusive culture that values innovation and people
• Exposure to cutting-edge technologies and projects

About Our Commitment

BCforward is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Interested? Apply Now!

If this sounds like the right opportunity for you, please apply with your most recent resume or contact:
Email: [Recruiter Email]
Phone: [Recruiter Phone Number]