Senior QA & Technical Operations Lead

Nashoba Valley Chamber of Commerce; Harvard (MA); On-site; USD 81,000 - 98,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and financial protection

Paid time off

Job summary

Devens site in Massachusetts seeks a Senior Specialist, QA Technical Operations to provide quality oversight across technology transfer, automation, cell bank disposition, validation, and site engineering. You will ensure products meet regulatory standards and support audits with a collaborative cross-functional team.

The role requires a BS in science or related field, 5+ years in regulated environments, and strong knowledge of US/EU cGMP.

Qualifications

• BS in science, engineering, biochemistry or related discipline (preferred).
• Minimum 5 years in a regulated environment with at least 3 years focused on product quality.

Responsibilities

• Supports and provides quality oversight to technology transfer documentation.
• Maintains SOPs for site Quality Assurance programs to ensure high-quality materials.
• Provides floor support to manufacturing processes as needed.
• Reviews and approves Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records.
• Oversees Quality walkthroughs for shutdown and inspection readiness and ensures compliance with procedures.
• Assists in regulatory inspections and participates in internal and external audits.
• Sets performance objectives for QA staff and provides coaching to improve unit performance.
• Reviews investigation records, CAPA records, change management, and automation updates.

Skills

Regulated environment experience

Quality oversight

Team collaboration

Electronic systems knowledge

Education

BS in science/engineering/biochemistry or related

Tools

SAP

LIMS

Infinity (Veeva Vault)

LES

Maximo

Vault

Syncade

Job description

Devens site in Massachusetts seeks a Senior Specialist, QA Technical Operations to provide quality oversight across technology transfer, automation, cell bank disposition, validation, and site engineering. You will ensure products meet regulatory standards and support audits with a collaborative cross-functional team.

The role requires a BS in science or related field, 5+ years in regulated environments, and strong knowledge of US/EU cGMP.