QC Compliance & Data Review Specialist III

R&D Partners is seeking to hire a QC Compliance & Data Review Specialist III in Frederick, MD.

Your main responsibilities as a QC Compliance & Data Review Specialist III:

· Communicate with QC Operations and cross-functional partners to coordinate data review, records completion, testing support, and resolution of quality-related issues.

· Monitor compliance with documented policies, applicable quality objectives, regulatory requirements, company procedures, and departmental practices.

· Review and interpret information contained in electronic and paper records, laboratory systems, reports, and controlled documents.

· Prepare and maintain accurate electronic records, written reports, metrics, presentations, and technical documentation.

· Use standard office and laboratory information systems for extended periods and participate in virtual or in-person meetings.

What we are looking for in a QC Compliance & Data Review Specialist III:

· Master's degree in a relevant scientific or technical discipline and 3+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; or Bachelor's degree in a relevant scientific or technical discipline and 5+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; or High school diploma or equivalent and 9+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment.

· Experience reviewing GMP laboratory data and managing or supporting quality records such as deviations, laboratory investigations, CAPAs, and change controls.

· Strong working knowledge of cGMP, Good Documentation Practices, data integrity principles, and applicable regulatory requirements, including 21 CFR Parts 11, 210, and 211.

· Demonstrated ability to review complex laboratory and compliance records, recognize deviations from approved practices, and document clear, evidence-based conclusions.

· Working knowledge of root cause analysis, laboratory investigations, risk assessment, CAPA, change control, and inspection-readiness practices.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance - PPO, HMO &
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$61,934 - $77,418 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.

The cornerstone of our success: a knowledgeable and experienced recruiting team.

Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.