GMP Lab Operations Pro (Cleanroom)

Actalent; Burlington (MA); On-site; USD 28,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan – Pre-tax and R

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking a Lab Operations Specialist in Burlington, MA to support GMP manufacturing by preparing materials, equipment, and maintaining a compliant ISO 7 cleanroom. The role collaborates with manufacturing, quality, and process development to ensure timely availability of materials while upholding cGMP standards.

This 100% onsite contract position emphasizes SOP adherence, documentation accuracy, and strict regulatory compliance.

Qualifications

• Experience in GMP environments with a strong emphasis on compliance and documentation.
• Familiarity with SOPs, work in a regulated cleanroom, and adherence to cGMP.
• Experience handling inventory for laboratory or manufacturing consumables.
• Ability to maintain accurate records and follow controlled processes.
• Knowledge of ISO 7 cleanroom requirements and material handling.
• Experience supporting QA/QC, validation, and process development activities.

Responsibilities

• Prepare materials, samples, and consumables for GMP manufacturing operations.
• Set up and verify equipment and supplies for production in an ISO 7 cleanroom.
• Support quality, manufacturing, QA, QC, validation, and process development teams.
• Perform sample and consumable preparation per SOPs and cGMP.
• Carry out sanitization to maintain a clean laboratory and controlled environment.
• Maintain and organize records per cGMP and document control practices.

Skills

GMP experience

Cleanroom operations

SOP compliance

Inventory management

Documentation accuracy

ISO 7 environment

Education

HS diploma/Associate

Job description

Actalent is seeking a Lab Operations Specialist in Burlington, MA to support GMP manufacturing by preparing materials, equipment, and maintaining a compliant ISO 7 cleanroom. The role collaborates with manufacturing, quality, and process development to ensure timely availability of materials while upholding cGMP standards.

This 100% onsite contract position emphasizes SOP adherence, documentation accuracy, and strict regulatory compliance.