QA Sr. Specialist GMP

Job Description

Job Description

R&D Partners is seeking to hire a QA Sr. Specialist GMP in Cambridge, MA.

Your main responsibilities as a QA Sr. Specialist GMP:

·      Review of event documentation such as Batch records, Exceptions, and Regulatory filings

·      Production record review and Product disposition for drug substance, drug product, device assembly and finished goods

·      Support design development plan including design verification and DHF deliverables

·      Build and maintain Product Specification Files (PSF) for company program

What we are looking for in a QA Sr. Specialist GMP:

·      Minimum, a BS degree in life sciences, engineering or related field

·      Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment

·      Good understanding of FDA and EMA regulations and guidelines

·      Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)

·      Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry 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:

$111,488 - $139,360 (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.

Company Description

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.\n\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\n\nOur 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.