Compliance Specialist CMC, Quality Assurance

SGS Consulting
Massachusetts

Job Responsibilities:

  • Essential Duties and Responsibilities include, but are not limited to, the following:
  • Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
  • Performs QA review of executed development studies intended for regulatory submissions, included but not limited to, draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
  • Identifies and reports documentation errors and deviations from test / data records, protocols, Standard Operating Procedures (SOPs), or specifications in a timely manner.
  • Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Skills:

  • Quality Assurance
  • Data Review
  • QA Review
  • GMP

Education/Experience:

  • BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
  • Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
  • Preferred Qualifications:
  • Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
  • Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
Posted 2025-11-14

Recommended Jobs

Environmental Services (Housekeeping) Brighton

Boston Medical Center
Cambridge, MA

Clean Cath/PV and EP labs Job Summary: Onsite Housekeeping position Location: Brighton, MA Per Diem/Casual Position Rotating work schedule (nights/evenings/days/weekends) According …

View Details
Posted 2025-12-15

RESEARCH SUPPORT ADMINISTRATOR, School of Public Health, Epidemiology

Boston University
Boston, MA

The Department of Epidemiology at the BU School of Public Health is seeking a Research Support Administrator responsible for coordinating everyday operations of several research grants related to soc…

View Details
Posted 2025-12-03

Family Medicine Physician

Greenlife Healthcare Staffing
Fitchburg, MA

Family Medicine Physician - Fitchburg, MA (#3170). Location: Fitchburg, MA. Employment Type: Full-Time. Salary: Up to $225,000 annually. Position Overview: Greenlife Healthcar…

View Details
Posted 2026-01-05

SLPA

A. Rose Pediatric Therapy Center
Fall River, MA

Responsibilities: * Working directly under the supervision of an SLP to treat and perform interventions with children aged 0-21 * Ability to establish rapport with children and families * Ability…

View Details
Posted 2025-08-28

Part Time Respite Nurse, Danvers, MA

Amergis Healthcare Staffing
Danvers, MA

Amergis Staffing is seeking a Respite Nurse to work in the community with adults with severe and persistent mental illnesses. The ideal candidate would possess knowledge of psychiatric medications, p…

View Details
Posted 2026-01-02

Communications Coordinator (Remote)

Cengage Group
Massachusetts

We believe in the power and joy of learning At Cengage Group, our employees have a direct impact in helping students around the world discover the power and joy of learning. We are bonded by our s…

View Details
Posted 2026-01-08

Senior Product Data Scientist

Bevi
Boston, MA

Bevi is on a mission to transform how beverages are delivered and consumed. Our smart hydration systems eliminate the need for single-use bottles and cans—making it easy, fun, and sustainable to stay…

View Details
Posted 2025-11-28

Home Health Aide

Guardian Angel Senior Services
Adams, MA

Home Health Aide  Flexible Hours Available/ Create your own schedule. Join our team and help take care of Elderly and Disabled individuals in the comfort of their own homes! At Guardian Angel Sen…

View Details
Posted 2026-01-06

Accounts Payable - Accounts Receivable (AP/AR) Specialist

ProPivotal Staffing
Boston, MA

Accounts Payable - Accounts Receivable (AP/AR) Specialist We are hiring an Accounts Payable - Accounts Receivable (AP/AR) Specialist to join our growing team. This position is newly created to s…

View Details
Posted 2025-12-27

Head of Logistics

Plasmidsaurus
Boston, MA

About Plasmidsaurus Plasmidsaurus is on a mission to accelerate new cures and promote a healthier planet by unlocking a new level of productivity for scientists. Our sequencing services are used d…

View Details
Posted 2026-01-10