QA Disposition Lead

job summary:

QA Disposition Specialist

Location: On-site & Remote

About the Role

The QA Disposition Manager serves as a key quality gatekeeper, responsible for batch review and disposition of Drug Substance (DS), Drug Product (DP), and Clinical Packaging & Labeling operations.

This role ensures compliant and timely product release, supports accelerated development programs, and applies sound technical judgment to protect clinical supply continuity.

Key Responsibilities

• Perform detailed review of MBRs/EBRs for DS and DP
• Authorize batch release within Smart Supply and applicable systems
• Review and approve labeling and packaging specifications (e.g., MELTS)
• Assess temperature excursions and deviation impact
• Provide ri
  QA Disposition Manager
  Location: On-site & Remote
  About the Role
  The QA Disposition Manager serves as a key quality gatekeeper, responsible for batch review and disposition of Drug Substance (DS), Drug Product (DP), and Clinical Packaging & Labeling operations.
  This role ensures compliant and timely product release, supports accelerated development programs, and applies sound technical judgment to protect clinical supply continuity.
  Key Responsibilities
• Perform detailed review of MBRs/EBRs for DS and DP
• Authorize batch release within Smart Supply and applicable systems
• Review and approve labeling and packaging specifications (e.g., MELTS)
• Assess temperature excursions and deviation impact
• Provide risk-based disposition decisions for complex or accelerated programs
• Partner cross-functionally to resolve deviations, CAPAs, and change controls
• Support inspection readiness and continuous improvement initiatives
• Qualifications
• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field
• 4+ years of progressive QA experience, including batch disposition authority
• Strong knowledge of global GMP regulations and clinical supply requirements
• Experience reviewing manufacturing records (DS/DP) and quality events
• Strong decision-making skills and ability to operate under tight timelines
• Excellent cross-functional collaboration and communication skills
• sk-based disposition decisions for complex or accelerated programs
• Partner cross-functionally to resolve deviations, CAPAs, and change controls
• Support inspection readiness and continuous improvement initiatives

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field
• 4+ years of progressive QA experience, including batch disposition authority
• Strong knowledge of global GMP regulations and clinical supply requirements
• Experience reviewing manufacturing records (DS/DP) and quality events
• Strong decision-making skills and ability to operate under tight timelines
• Excellent cross-functional collaboration and communication skills

location: Cambridge, Massachusetts
job type: Outsourcing Project
salary: $70,000 - 80,000 per hour
work hours: 9 to 5
education: Bachelors


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.