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

Aspirus Health

Director, System Care Coordination Job at Aspirus Health

 ...coordination, case mangement, or utilization review in an integrated healthcare delivery system and/or health plan. Extensive knowledge of payer mechanisms, clinical utilization management, outcome measures and patient information systems in including Pathways, HEDIS, etc.... 

ROSS Decco

Maintenance Technician Job at ROSS Decco

 ...coils and solenoids for over 100 years. Serving a broad range of industries, Decco brings industrial solenoid technology to customers...  ...presses and various hand and power tools to perform repair and maintenance work. Builds or assembles racks, shelves, tables, and... 

SmartEdge

Entry Level Marketing Manager Job at SmartEdge

 ...We are in need of an Entry Level Marketing Manager to help with executing our sales and marketing campaigns for our new clients. With our company's work ethic and strategy, we far surpass our client's own capability to do the work on their own. We are looking for candidates... 

Lee Health

EKG Technician III Job at Lee Health

 ...that are provided by the Lee Health Cardiovascular Department. Technicians must be proficient in performing EKGs, rhythm strips, stress tests...  ...required. Experience:Minimum of 2 years of experience as an EKG Technician II preferred, performing EKG, Stress and Holter... 

Parkland Health and Hospital System

Police Dispatcher Job at Parkland Health and Hospital System

 ...Its our passion. Primary Purpose Receives, records and dispatches service calls and requests to ensure that security and public safety...  ...assistance and radio dispatch officers to provide appropriate police response. 2. Operate National and State Criminal Information...