Job Description

PharmaLex is looking to expand its Quality Assurance and Compliance consulting network! Although qualifications will vary depending on the specific project, in general clients are looking to engage Quality Assurance Specialist and Senior Specialists with 3-15+ years of experience working in a regulated FDA environment.

MINIMUM QUALIFICATIONS:

• At least 3-10 years DIRECT EXPERTISE WORKING WITHIN THE PHARMACEUTICAL, BIOTECH, OR MEDICAL DEVICE INDUSTRY (required for all positions)
• Hands-on experience with quality management system (i.e. training, metrics, documentation management)
• Experience working in a regulated environment under FDA GCP, GLP, and/or GMP regulations
• Understanding of change control principles and work flow
• Background on Deviations, Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) management
• Familiarity with documentation control practices, including writing and revision of policies, SOPs and work instructions
• Batch records review and approval for clinical and commercial products
• Experience with Quality Control
• Understanding of product approval and life cycle processes
• Compliance review experience (i.e. laboratory data review, product release)
• Aptitude for increasing efficiencies and improving processes
• Excellent attention to detail
• Cell and gene therapy exposure is a plus
• Experience with QMS and/or EDMS / QMS software preferred (i.e. Trackwise, MasterControl, Veeva Vault, etc)

LOCATION

· Massachusetts: Worcester, MA - Cambridge, MA and surrounding areas

Company Description

PharmaLex is the largest global service provider of regulatory affairs, quality management and compliance, pharmacovigilance and development consulting, in the pharmaceutical and medical device industry. We specialize in effectively supporting all aspects of product development – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees. The PharmaLex team continues to expand within the US and globally.