Gmp Specialist

Job Description

Job Description

Job Title: GMP Specialist

Job Description

We are seeking a GMP professional to support technical transfer, process development, GMP trial execution, process validation, and ongoing manufacturing oversight across multiple third-party manufacturing sites. This role ensures compliance with 21 CFR 117 (FSMA Preventive Controls) and supports intermediate and finished food/supplement products.

This is a part-time position (30–50%) with travel to U.S.-based co-manufacturers.

Responsibilities

• Lead GMP trial planning and execution for technical transfer, production, and validation.
• Provide on-site manufacturing support at co-manufacturing facilities.
• Analyze production data to assess process performance, variability, and validation readiness.
• Develop and support technical transfer packages, batch records, and manufacturing instructions.
• Ensure all work is thoroughly documented and audit-ready.
• Partner with co-manufacturers to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Establish process controls, acceptance criteria, and monitoring strategies.
• Design and execute process validation protocols.
• Maintain compliant, defensible validation documentation.
• Support technical qualification and approval of co-manufacturers.
• Evaluate manufacturing capabilities, process controls, and FSMA compliance gaps.
• Identify scale-up, consistency, and food safety risks and implement mitigation strategies.
• Support related manufacturing, process improvement, or technical initiatives as needed.

Essential Skills

• Hands-on experience leading process validation and GMP trials under 21 CFR 117.
• Proven experience with technical transfer to third-party manufacturers.
• Strong working knowledge of FSMA Preventive Controls.
• Experience in food or dietary supplement manufacturing.

Additional Skills & Qualifications

• Exposure to spray drying, soft gel manufacturing, distillation, or lipid chemistry strongly preferred.
• Ability to develop manufacturing documentation, templates, spreadsheets, and monitoring tools.
• Spanish proficiency preferred.

Work Environment

This role can be 100% remote with expectations of traveling to different co-manufacturing sites as needed, including locations such as Hadley, MA, Minnesota, NY, and Ohio. When traveling to a site, anticipate being there for 2-3 days at a time. Travel will not be required every week, but as needed.

If you are interested, please book a virtual meeting with me here:

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

The pay range for this position is $50.00 - $70.00/hr.

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)

This is a hybrid position in Hadley,MA.

This position is anticipated to close on Apr 24, 2026.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.