Senior QA Specialist – Plant Operations (GMP)

RoslinCT; Hopkinton (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Educational assistance

Job summary

RoslinCT is seeking a Senior QA Specialist – Plant Operations to provide QA support for manufacturing operations, review batch records, and ensure GMP documentation aligns with internal procedures. The role focuses on maintaining product quality and regulatory compliance in a fast-paced biotech setting.

The ideal candidate has 5–8 years of QA experience in pharma/biotech with internal manufacturing, and strong communication skills to mentor teams and collaborate across departments.

Qualifications

• 5-8 years of relevant QA experience in pharma/biotech with internal manufacturing.
• Cell therapy experience preferred.
• Strong knowledge of cGMP and ICH guidelines.
• Excellent verbal and written communication skills.

Responsibilities

• Support day-to-day QA operations, including batch record review and QC testing record reviews to ensure compliance with procedures.
• Assist in product disposition and deviation investigations, CAPA and Change Control implementations.
• Develop training materials and deliver training for QA procedures.
• Monitor implementation of QA procedures for compliance and identify opportunities for improvement.
• Provide QA review and approval of plant SOPs and GMP documentation.
• Mentor QA staff and cross-functional teams on GMP compliance and quality culture.

Skills

Quality Assurance

GMP compliance

ICH guidelines

MS Office

Job description

RoslinCT is seeking a Senior QA Specialist – Plant Operations to provide QA support for manufacturing operations, review batch records, and ensure GMP documentation aligns with internal procedures. The role focuses on maintaining product quality and regulatory compliance in a fast-paced biotech setting.

The ideal candidate has 5–8 years of QA experience in pharma/biotech with internal manufacturing, and strong communication skills to mentor teams and collaborate across departments.