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

Rise Technical

Project Superintendent Job at Rise Technical

 ...Coral, Florida (Onsite) $110,000 - $120,000 + Progression to Senior roles + Excellent PTO + Bonus + Fantastic Benefit Package (Medical, Dental, Vision) Excellent opportunity for a Project Superintendent to join a well-established and growing multifamily developer... 

Find Great People | FGP

Design Engineer Job at Find Great People | FGP

 ...The Design Engineer is an entry-level position where associates are heavily supervised and are expected to learn and assist with all engineering design aspects of a project. Once trained, associates in this position will be responsible for their own design projects and... 

United Surgical Partners International, Inc

Surgery Center Administrator Job at United Surgical Partners International, Inc

 ...Partners International (USPI), the country's largest Ambulatory Surgery Center platform, is seeking an RN/Surgery Center Administrator...  ...evaluated by their respective managers, ensuring that reviews occur as scheduled or at least annually for each employee. Review and approve... 

Consultant Specialists, Inc. (CSI)

Facilities Technician Job at Consultant Specialists, Inc. (CSI)

 ...Facilities Technician II is responsible for performing a wide range of skilled maintenance, troubleshooting, repair, and operational support activities across the facility, grounds, and building systems. Duties include but are not limited to the following:... 

Confidential RE Company

Property and Asset Operations Manager - Hawaii Job at Confidential RE Company

 ...Review monthly financials and identify risks and variances Oversee CAM reconciliations and expense recoveries Interpret lease language related to expenses and tenant obligations Serve as escalation point for tenant, vendor, and compliance matters Coordinate...