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

38° North Latitude Builders, Inc.

Casework and Millwork Designer Job at 38° North Latitude Builders, Inc.

 ...constructive teamwork Willingness to learn and adapt to situations Start: Immediately Type : Full-Time or Part-Time Location: San Rafael, CA Salary: Based on experience Schedule : Monday Friday, 6:30am 3:00 pm Benefits: Medical, Dental, Vision... 

ARDAGH GROUP

Chemical Process Operator Job at ARDAGH GROUP

 ...PURPOSE OF THE JOB: ~ The Chemical Process Operator performs all chemical process tests required to maintain chemical balance and material mixtures necessary for operation. Complies with safety related SOP in Chemical handling. KEY ACCOUNTABILITIES: Operate... 

Medix™

Certified Medical Coder - 248716 Job at Medix™

 ...Hiring a REMOTE Certified Medical Coder that lives in Arizona! Schedule: M-F 8-5 PM MST Pay Range: Between $25-$29/hr depending...  ...to day: Expertly assign and sequence diagnostic/procedural codes (ICD-10, CPT, etc.) per payer regulations and industry standards... 

Stellar

Senior Mechanical Engineer Job at Stellar

 ...the candidate can design such systems with limited direction, can mentor others, and be capable of supervising the work of other engineers and designers while serving as the lead engineer on any given project. The candidate must have a working knowledge of the International... 

Wrightwell

Vice President Asset Management Job at Wrightwell

 ...This role is based in Atlanta, GA and requires a minimum of 3 days per week in office. Key Responsibilities: Acquisitions Support Assist in the identification, evaluation, and execution of Build-to-Rent acquisitions across the U.S. Conduct financial and...