Product Quality Lead

Alkermes • Waltham, MA

3d • $128,000 - $142,000 • Onsite

About The Position

Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral solid dosage (OSD) manufacturing and analytical activities, with primary focus on analytical lifecycle oversight (instrument qualification, method validation, stability, and data review), cleaning validation for manufacturing equipment, and QA support batch manufacturing. Ensure all activities are executed in full compliance with FDA/EU cGMP requirements and internal quality standards, and support batch disposition through robust data review and cross-functional collaboration.

Requirements

• Onsite Quality Assurance (QA) support for Phase I/II oral solid dosage (OSD) manufacturing and analytical activities.
• Analytical lifecycle oversight (instrument qualification, method validation, stability, and data review).
• Cleaning validation for manufacturing equipment.
• QA support batch manufacturing.
• Full compliance with FDA/EU cGMP requirements and internal quality standards.
• Robust data review and cross-functional collaboration for batch disposition.

Responsibilities

• Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral solid dosage (OSD) manufacturing and analytical activities.
• Focus on analytical lifecycle oversight including instrument qualification, method validation, stability, and data review.
• Oversee cleaning validation for manufacturing equipment.
• Provide QA support for batch manufacturing.
• Ensure all activities are executed in full compliance with FDA/EU cGMP requirements and internal quality standards.
• Support batch disposition through robust data review and cross-functional collaboration.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed