Quality Control Analyst IV Job at Meet Life Sciences, Cambridge, MA

dzA3R2tMeklOUnZ3azhGYTY5Ry9rYjM4eGc9PQ==
  • Meet Life Sciences
  • Cambridge, MA

Job Description

*W2 Only

Overview:

The Analyst IV is responsible for ensuring quality and compliance standards are met to support the commercialization of pharmaceutical/biotech programs. This role ensures completeness, consistency, and accuracy of regulatory filings, laboratory data, and reports through thorough review processes. This position offers remote flexibility with occasional on-site presence in Norton, MA, and Cambridge, MA, and potential travel to CMO/CTL sites.

Key Responsibilities:

  • Verify integrity and traceability of regulatory dossier sections against reference methods and reports.
  • Review analytical data for accuracy, completeness, and correct entries, including electronic data and laboratory documentation (notebooks, worksheets, logbooks).
  • Ensure complex notebooks for analytical method validation, verification, and transfer testing are compliant with approved protocols.
  • Audit electronic data trails to confirm adherence to applicable procedures.
  • Resolve data discrepancies with clients and ensure all corrections are implemented.
  • Adhere to SOPs and cGMP standards, providing management with regular updates on deviations or discrepancies.
  • Suggest improvements to the review process and perform other assigned duties as needed.

Qualifications:

  • B.S. in Chemistry, Biology, Biochemistry, or related scientific field.
  • Minimum 5 years of experience in GMP Quality Control within the pharmaceutical/biotech industry.
  • Experience with method transfer, analytical method implementation, and method lifecycle management.
  • Strong technical writing, data analysis, and problem-solving skills, including CAPA implementation.
  • Excellent organizational, communication, and teamwork abilities.
  • Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Job Tags

Remote job,

Similar Jobs

Greensburg Central Catholic JuniorSenior High School

School Custodian Job at Greensburg Central Catholic JuniorSenior High School

 ...Position Summary Greensburg Central Catholic is seeking a reliable School Custodian to help maintain a clean, safe, and welcoming environment for students, staff, and visitors. The custodian plays an essential role in supporting daily school operations and upholding... 

Concrete Strategies LLC.

Office Administrator Job at Concrete Strategies LLC.

 ...Concrete Strategies is seeking a detail-oriented and dependable Office Administrator to provide full-spectrum administrative support...  ...documentation and archiving of administrative and personnel forms Assist with onboarding paperwork and orientation tasks for new hires... 

Bank of America Corporation

Sr Fraud Analyst II - Global Payments Ops Job at Bank of America Corporation

 ...make an impact. Join us! This job is responsible for reviewing complex products for the prevention and detection of possible fraud. Key responsibilities include researching and analyzing of account activity to assess levels of risk and fraud. Job expectations include... 

BellaVista Landscape Services Inc.

Senior Administrative Assistant Job at BellaVista Landscape Services Inc.

 ...professionalism, discretion, and customer service. Ability to work independently and collaboratively with multiple departments....  ...years experience of administrative or office experience, and data entry. Typing and 10-key skills at productive speed or above. Strong... 

A&W Canada

Restaurant Manager Job at A&W Canada

 ...team from their local community! The Restaurant Manager/Assistant Manager duties include, but are...  ...Monitoring and controlling labour costs and food costs Working as a team with co-...  ...which involve the day to day operation of a fast food restaurant Working Conditions:...