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

Element Materials Technology

Safety Health and Security Specialist Job at Element Materials Technology

 ...Element is hiring a proactive and knowledgeable Safety, Health & Security Specialist to support and advance our organizations safety...  ...promoting a Zero Harm mindset across all locations. Element is a global provider of lab-based Testing, Inspection and Certification... 

Lifepoint Health®

Resource Clinical Liaison Job at Lifepoint Health®

 ...Title: Resource Clinical Liaison (RN, PT, OT, SLP) - Inpatient Rehab Job Type: Full Time Location: Based in the Dallas-Fort Worth...  ...day, five days a week, under the supervision of a rehabilitation physician. ~ State-of-the-Art Facility : Offers modern therapy... 

Prairie Band Health Services

Family Nurse Practitioner - Family & Outpatient Care Job at Prairie Band Health Services

 ...active Washington State NP license Prior IHS, tribal, or government healthcare experience preferred Background in Family Medicine...  ...Local candidates welcome Responsibilities As a Family Nurse Practitioner, you will provide comprehensive outpatient services... 

Allure Bridals

Graphic Designer & Video Editor Job at Allure Bridals

Graphic Designer & Video Editor Allure Bridals Memphis, TN Full-Time | Hybrid About the Role Allure Bridals is seeking a talented Graphic Designer & Video Editorto support our creative team in producing high-quality visual content across our family of brands...

The Carrera Agency

DevOps - System Engineer Job at The Carrera Agency

 ...We are seeking a skilled DevOps - Systems Engineer to design, implement, and maintain cloud and DevOps infrastructure with a focus on reliability, scalability, and security. This role offers the opportunity to work with a great team on data-intensive workflows, bioinformatics...