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

Betacom

Project Manager - Commerce City, CO Job at Betacom

 ...where Markets may be missing billable items, and track the management of those change orders. Oversee and drive achievement of SLA/OLA agreements. Familiarizes themselves with all Customer contracts and oversees Company compliance with those contracts. Should... 

The BAM Companies

Videographer/Editor Job at The BAM Companies

 ...talented and detail-oriented Videographer/Editor to join our creative team. The ideal candidate will have a strong background in video production, with proficiency in Adobe After Effects and Premiere Pro, and knowledge of cameras (Sony preferred). This roles... 

US Tech Solutions

Data Entry Clerk Job at US Tech Solutions

 ...Job Title: Data Entry Operator Duration: 05 Months Contact with possible extension Location: Columbus, OH 43215 - Remote work Job Description: Responsibilities: Performs advanced data entry duties. Can support multiple data entry tasks in various... 

Hubler Ford

Courier/Driver Job at Hubler Ford

Hubler Ford is seeking a reliable and efficient Courier/Driver to join our team in Shelbyville, IN. This role involves timely and safe delivery of vehicles, parts, and documents to various locations while providing excellent customer service.Responsibilities* Safely... 

Kids 'R' Kids Concord

Summer Camp - After School Teacher Part Time or Full Time Job at Kids 'R' Kids Concord

The Summer Camp / before & aftercare teacher will create lesson plans and follow through with implementing them in the classroom in order to support students academic, emotional, physical, social, and creative development with students K-6th Grade. Teachers will recognize...