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

Pentangle Tech Services | P5 Group

Design Engineer Job at Pentangle Tech Services | P5 Group

 ...experience overall Minimum 3 years experience with Airbag Design Minimum 1 years experience with Curtain Airbag Design Minimum...  ..., and supported structural design using CAD tools. Created engineering drawings, interpreted blueprints, and collaborated with... 

The TEA Center

Preschool Teacher fluent in Spanish or French language Job at The TEA Center

Looking to be part of a growing successful child care center? As a Preschool teacher at the Transformational Education Adventure Center, you will be part of a fast paced business while making a difference in the lives of children. Prefer candidates with a CDA or a degree...

Taurus Industrial Group, LLC

Environment, Health and Safety Manager Job at Taurus Industrial Group, LLC

 ...leadership role in overseeing and advancing the Health, Safety, and Environmental (HSE) performance across all industrial construction projects...  ...or Associates degree in Occupational Safety, Environmental Science, Construction Management, Engineering, or related field, with... 

ERISA Recovery

Legal Claims Analyst Job at ERISA Recovery

 ...ERISA Recovery are experts in collecting complex and aged claims through the Federal ERISA appeals process. We are a fast-growing organization...  ...working in the legal field ~2+ years working with healthcare insurance claims (preferred)~ Strong Communication skills ~ Working... 

Neudesic, an IBM Company

Principal Consultant - Cloud Infrastructure Job at Neudesic, an IBM Company

 ...with Integrity. If these attributes mean something to you - we'd like to hear from you. Role Profile Neudesic Principal Consultants on our Cloud Infrastructure Services team are thought-leaders for clients, with a successful history of providing unique, well...