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

Milevista Group

Brand Promoter Job at Milevista Group

 ...Job Summary We are looking for an enthusiastic and outgoing Brand Promoter to join our team onsite in Los Angeles, CA . This entry-level role is perfect for someone who enjoys interacting with people, representing brands with professionalism, and supporting live... 

Farm Job Search

Dairy Farm Manager Job at Farm Job Search

 ...Dairy Farm Manager (6207) Location: Iowa JobNumber: 6207 Dairy Farm Manager position immediately available on a 500 plus cow dairy in Northeastern Iowa. Owner travels extensively and requires a farm manager to oversee the operation in his absence. Must have dairy... 

Brock Canada Field Services Ltd

Third Year Scaffolders - IPC Blackrod Job at Brock Canada Field Services Ltd

Brock Canada Field Services is looking for Journeyperson Scaffolders to Join the Team at IPC Blackrod starting January 28, 2026! Shift: 14/7 Hours: 12Hour Days (8 ST & 4OT) Travel: Drive-in/out - Must have your own reliable vehicle to get to and from camp...

The Pivot Group Network

CNC Machinist - Delta Township Area Job at The Pivot Group Network

 ...CNC Machinist | Delta Township, MI Salary Range: $49,000 - $81,000 depending on experience Are you a seasoned professional with a passion for precision machining and producing high-quality parts? The Pivot Group is committed to fostering meaningful relationships... 

BorgWarner Inc.

Systems Integration Engineer Intern Job at BorgWarner Inc.

 ...Position Systems Integration Engineer Intern Location Kokomo, Indiana About Us BorgWarner is a global product leader in delivering innovative and sustainable mobility solutions. We are a company of innovators and independent thinkers that brings...