Contract - Quality Control Analyst

Company: Real Staffing
Location: Cambridge
Posted on: May 12, 2022

Job Description:

Location:Cambridge, Massachusetts, United States Title: Contract - Quality Control AnalystLocation: Cambridge - Hybrid (1 or 2 days onsite)Duration: 6+ Month contractAbout the Company: A global Pharmaceutical CompanyBenefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.About the Role: The Quality Control Analyst II will work within the Quality Control Technical Service (QCTS) group, managing and maintaining the documents and quality records for late stage and commercial product specifications of the therapeutic programs for the management of product-lifecycles.Your Main Responsibilities

• Manages late stage and commercial documents for the release and stability specifications of drug programs
• Responsible for lifecycle management of specifications and justification of specification reports. Responsible for coordinating QC impact assessments as part of quality records (change controls, CAPAs, deviations, etc) for specifications.
• Maintains ad hoc meetings with the Specification Review Board, a cross-functional team, to support the lifecycle of early (in partnership with Analytical Sciences), late, and commercial programs.
• Supports multiple CMC program teams by providing documents in a timely manner.
• The role requires regular interactions with senior members of cross functional teams and provides project management and Subject Matter Expert (SME) knowledge for product specifications (API, drug product, intermediates, and potentially critical starting materials) to support CMC teams.
• Perform data verifications (data integrity review), support analytical method validations, and perform statistical analysis of data, as needed.Requirements
  • 5+ years of experience in an industrial setting, preferably in a cGMP environment as it pertains to the biopharmaceutical industry
  • Contributes substantially to the interpretation of data and subsequent impact to methods/products.
  • Working knowledge of statistical analysis of data, lifecycle management of late-stage and commercial products, and commitment to data integrity. The successful candidate would have a good command of technical writing in English.
  • Prior experience with relevant ANVISA, EMA, FDA, ICH, and JP guidelines as it pertains to drug substance and drug product specifications
  • Knowledge of regulatory processes in relation to filings and marketing applications for Module 3 (amendments, CTD, IMPD, IND, NDA, MAA, etc.)
  • Strong collaborative, communication, and time management skills
  • Sound judgement and commitment to transparency and integrityEOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Cambridge , Contract - Quality Control Analyst, Professions , Cambridge, Massachusetts