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

Pride Health

Certified Nursing Assistant Job at Pride Health

 ...etc.) as ordered and reports amount, color, and consistency to nurse-in-charge. Gives incontinent and skin care to residents as is...  ...terminally ill, isolated, debilitated, or cognitively impaired. Assists residents from bed to chair, stretcher and vice versa with use... 

Connecticut Innovations

Summer 2026 Venture Team Intern | Venture Debt Job at Connecticut Innovations

 ...photonics, and advanced materials . As an intern, youll get hands-on experience with...  ...capital and lending. Venture Debt Team Internship Join CIs Venture Debt Team to...  ...lead generation, sourcing, and business development activities Qualifications... 

DermCare Management

Mohs Surgeon/Dermatologist Job at DermCare Management

 ...procedures Established patient base with strong referral network Work alongside a team of experienced dermatologists, Mohs surgeons, and advanced practice providers Access to state-of-the-art facilities and technology Supportive clinical and administrative... 

David S. Brown Enterprises, Ltd

Leasing Consultant Job at David S. Brown Enterprises, Ltd

 ...members. Must have working knowledge of personnel, accounting, leasing, maintenance, computers, marketing and resident retention...  ...lease packages Complete move in package, test keys and inspect apartments prior to move in Conduct new resident orientation Participate... 

Mutual of Omaha Mortgage

Call Center Sales Representative Job at Mutual of Omaha Mortgage

 ...Call Center Sales Representative Irvine, CA - On-Site $24 an hour + bonus Full-Time Company Overview: Mutual of Omaha is a Fortune 300 Company. Mutual Omaha Mortgage is inspired by hometown values and a commitment to being responsible and caring for each...