Lab Operations Specialist

Lab Operations Specialist

The Lab Operations Specialist supports GMP manufacturing operations by preparing materials and equipment, maintaining a compliant cleanroom environment, and ensuring all activities align with cGMP and ISO 7 standards. This role works closely with manufacturing, quality, and process development teams to keep operations running smoothly and efficiently in a highly regulated setting.

Responsibilities

• Prepare all materials, samples, and consumables required to support GMP manufacturing operations.
• Set up, stage, and verify equipment and supplies needed for production activities in an ISO 7 cleanroom.
• Support quality, manufacturing, QA, QC, validation, and process development functions by ensuring timely availability of materials and equipment.
• Perform sample preparation and consumable preparation according to established procedures and cGMP requirements.
• Carry out sanitization activities to maintain a clean and controlled laboratory and cleanroom environment.
• Manage document control activities by accurately completing, organizing, and maintaining records in compliance with cGMP standards.
• Maintain inventory of consumables and materials, including tracking stock levels, organizing storage, and supporting timely replenishment.
• Identify and escalate issues related to equipment, processes, or product quality to the appropriate stakeholders.
• Support continuous improvement efforts by recognizing opportunities to enhance processes, efficiency, and compliance.
• Ensure all equipment is properly cleaned, maintained, and ready for use, following validation and qualification requirements.
• Follow standard operating procedures (SOPs) and adhere to all regulatory and internal quality guidelines in daily work.
• Collaborate with cross-functional teams to support smooth and efficient GMP operations within the cleanroom.

Essential Skills

• Experience working in a GMP environment, with at least 2+ years of relevant experience.
• High school diploma or associate's degree.
• Ability to follow SOPs and work effectively in a highly regulated cleanroom GMP environment.
• Experience in pharmaceutical, biotechnology, or medical device settings.
• Hands-on experience with sample preparation and consumable preparation.
• Knowledge of and adherence to cGMP standards and document control practices.
• Experience with inventory management for laboratory or manufacturing consumables.
• Ability to support operations in an ISO 7 cleanroom environment.
• Strong attention to detail and accuracy in documentation and material handling.
• Ability to identify and escalate equipment, process, and quality issues in a timely manner.

Additional Skills & Qualifications

• Familiarity with laboratory operations in a GMP setting.
• Experience supporting QA, QC, validation, and process development activities.
• Comfort working with sanitization procedures and maintaining controlled environments.
• Strong organizational skills for managing consumables and inventory.
• Interest in contributing to continuous improvement initiatives within manufacturing operations.
• Motivation to grow within a successful, expanding organization and develop deeper GMP expertise.

Work Environment

This role is 100% onsite in a GMP-regulated ISO 7 cleanroom and laboratory environment. The schedule runs Tuesday through Saturday from 8:00 a.m. to 4:30 p.m. You will work closely with manufacturing, quality, and process development teams in a highly regulated setting that emphasizes cleanliness, documentation accuracy, and adherence to SOPs. The organization is experiencing strong growth, offering opportunities to develop skills and advance within a supportive team culture. Appropriate cleanroom attire and personal protective equipment are required and provided as part of daily operations.

Job Type & Location

This is a Contract position based out of Burlington, MA.

Pay and Benefits

The pay range for this position is $24.00 - $24.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Burlington, MA.

Application Deadline

This position is anticipated to close on Sep 29, 2026.