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

Whole Foods Market

Overnight Grocery Team Member (Stocker, Inventory, Receiving) - Part Time Job at Whole Foods Market

160 Littleton Road, Westford MA 01886-3190, United States 10620-WSF Westford Provides overnight support for assigned team to include receiving and preparing product and maintaining the floor, displays, and back stock in accordance with company standards.All Whole Foods ...

LHH

Customer Service Representative Job at LHH

 ...Customer Service Specialist Sacramento, CA (onsite)$20-22/hr Do you have at least one year of customer service experience either from...  ...retail? Do you have excellent communication skills and able to work in a fast paced environment? We are looking for a customer... 

The UPS Store #0318, #6132, #5901

Part-Time Center Associate Job at The UPS Store #0318, #6132, #5901

The Part-Time Center Associate delivers world-class customer service to all retail customers by receiving and processing packages for courier...  ...* Continuously practices good listening skills with customers, UPS Store team members, and leadership* Work at the self serve... 

Delta Downs

Bartender Job at Delta Downs

Company Description Boyd Gaming Corporation has been successful in gaming jurisdiction in which we operate in the United States and is one of the premier casino entertainment companies in the United States. Never content to rest upon our successes, we will continue ...

Addison Group

Senior Real Estate Attorney Job at Addison Group

 ...organizational, and leadership skills. Admission or eligibility for Colorado Bar. Proficiency with MS Word, Outlook, and standard legal research tools. Demonstrated ability to work independently in a fast-paced environment with multiple priorities....