Lead QA, Technical Operations (Biologics)

Bristol Myers Squibb; Shirley (MA); Hybrid; USD 86,788 - 91,458; Full time

Benefits offered by this job

Comprehensive health coverage

401(k) plan

Referral bonus program

Job summary

A leading biopharmaceutical company in Massachusetts is seeking a Quality Operations Specialist. The role focuses on oversight of technical transfer documentation and ensuring compliance with regulations. Candidates should have a B.S. in a related field and at least 8 years of relevant experience in a regulated environment. This position offers an hourly compensation range of $63-$66.39, with 50% onsite work required. Join us to contribute to the quality of biopharmaceutical manufacturing and technical operations.

Qualifications

• 8+ years of relevant experience in a regulated environment with at least 4 years focused on product quality.
• Extensive knowledge of US and EU cGMP regulations.
• Experience working in a team-based environment.

Responsibilities

• Support technical transfer documentation review and approval.
• Oversee risk assessments for Biologics and Facility Controls.
• Ensure compliance with external regulatory and internal guidelines.

Skills

Knowledge of biotech bulk and finished product manufacturing

Analytical testing

Understanding of facility and cross-contamination controls

Excellent communication skills

Education

B.S. in science, engineering, biochemistry or related discipline

Tools

Infinity (Veeva Vault)

Job description

A leading biopharmaceutical company in Massachusetts is seeking a Quality Operations Specialist. The role focuses on oversight of technical transfer documentation and ensuring compliance with regulations. Candidates should have a B.S. in a related field and at least 8 years of relevant experience in a regulated environment. This position offers an hourly compensation range of $63-$66.39, with 50% onsite work required. Join us to contribute to the quality of biopharmaceutical manufacturing and technical operations.