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Quality Assurance Consultant (Pharmaceutical, Biotech) -Waltham, MA

PharmaLex US Corp. Waltham, MA
  • Posted: over a month ago
  • Contractor
  • Benefits: Vision, Medical, 401k, Dental

PharmaLex is looking to expand its Quality Assurance consulting network!

Although qualifications will vary depending on the specific project, in general clients are looking to engage Quality Assurance Managers or Directors with at least 5 – 10 years of experience working in a regulated FDA environment.

Minimum Qualifications:

- At least 5-10 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)

· Robust understanding of change control principles and work flow

· Strong 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

· Compliance review experience (i.e. laboratory data review, product release)

· Aptitude for increasing efficiencies and improving processes

· Auditing experience preferred

·Experience with QMS and/or EDMS / QMS software preferred (i.e. Trackwise, MasterControl, Veeva Vault, etc)

Location

· Massachusetts: Waltham/ Watertown/ Boston / Cambridge and surrounding areas

PharmaLex US Corp.

PharmaLex (previously Complya) is a dynamic, rapidly-growing Life Sciences Consulting firm that provides Quality Assurance and Regulatory Affairs consulting support to companies in the biotechnology, pharmaceutical and medical device sectors. Complya started in 2007 and has grown to an active team of nearly 60 consultants with an extended network of dozens of consultants located in strategic cities throughout the United States, Europe, and Asia. Through a recent strategic merger with PharmaLex (a leading specialist provider of scientific affairs, regulatory affairs, pharmacovigilance and development consulting) Complya is now able to expand its reach and draw upon a deeper bench of resources in order to offer valuable new services to our clients in Boston and beyond. 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.

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