Overview
QA/QC Consultant Jobs in Boston, MA at Pioneer GMP Consulting
Title: QA/QC Consultant
Company: Pioneer GMP Consulting
Location: Boston, MA
QA Consultant – Quality Assurance (QC Support)
Candidate Deck: QA/QC Consultant Candidate Deck
Pioneer GMP Consulting partners with pharmaceutical, biotech, and CDMO organizations to deliver technical expertise across GMP-regulated environments. As demand continues to grow—particularly across North Carolina and the Research Triangle—we are expanding our team of Quality Assurance consultants who support laboratory and QC-focused initiatives.
We are looking to connect with experienced QA professionals who want to be part of a true
consulting team—working alongside Pioneer leadership and other consultants to support meaningful, high-impact projects across the life sciences industry.
Our consultants represent Pioneer on client engagements, providing QA oversight and support across laboratory operations, analytical methods, and quality systems.
What You’ll Support
We work with clients across a range of technical and operational disciplines, including:
Our QA consultants play a critical role in ensuring quality and compliance across QC and laboratory functions. Typical responsibilities include:
Laboratory Investigations & QA Review
- Quality review and approval of laboratory investigations, including:
- Out of Specification (OOS)
- Out of Trend (OOT)
- Atypical results
- Laboratory deviations and nonconformances
- Support root cause investigations, impact assessments, and CAPAs
Change Control & Documentation Oversight
- Provide QA oversight of change controls related to:
- Laboratory methods
- Instrumentation
- Specifications and procedures
- Review and approve controlled GMP documentation, including:
- SOPs, forms, specifications, protocols, and reports
- Support document control and change control implementation activities
Analytical Methods & Validation
- Provide QA oversight across the analytical method lifecycle, including:
- Method qualification, validation, verification, and transfer
- Review and approve validation and qualification protocols, reports, and supporting documentation
- Support phase-appropriate implementation of analytical methods, including cell therapy testing
Equipment & Systems Quality Support
- Provide QA support for laboratory equipment qualification activities:
- IQ/OQ/PQ documentation review
- Calibration and maintenance record review
- Periodic lifecycle documentation review
Typical Client Projects
Our QA consultants support initiatives such as:
- Laboratory startup and expansion efforts
- Analytical method validation and transfer programs
- Investigation remediation and CAPA effectiveness improvements
- Quality system enhancements and inspection readiness
- Cell and gene therapy program support
Who We’re Looking For
Successful consultants typically bring:
- Experience working in GMP-regulated pharmaceutical, biotech, or CDMO environments
- Background supporting manufacturing, engineering, validation, quality, or technical operations
- 5+ years of Quality Assurance experience in GMP-regulated pharmaceutical or biotech environments
- Experience supporting QC laboratories and analytical testing
- Strong experience with investigations, change controls, and GMP documentation
- Familiarity with cell therapy, gene therapy, or biologics (preferred)
- A willingness to travel
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related scientific discipline
- Strong communication, collaboration, and problem-solving skills
Working knowledge of:
- cGMP regulations (21 CFR Parts 210, 211; familiarity with 1271 preferred)
- ICH Q2
About Pioneer GMP Consulting
At Pioneer GMP Consulting, our consultants are an extension of our clients’ teams—helping organizations solve complex challenges across manufacturing, quality, engineering, and compliance.
We focus on building long-term relationships with experienced professionals, connecting them with meaningful projects while providing the support of a collaborative consulting team.
If you’re interested in learning more about Pioneer and the types of QA/QC-focused projects we support, we’d welcome the opportunity to connect.
