Gmp Specialist
Actalent, Hadley, MA, United States
Job Title
GMP Specialist
Pay and Benefits The pay range for this position is $50.00 - $70.00 per hour.
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.
Requirements Eligibility requirements may apply to benefits and may depend on your job classification and length of employment. For this temporary role, benefits may include medical, dental, and vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; disability; health spending account; transportation benefits; employee assistance program; and paid time off.
Application Deadline This position is anticipated to close on Apr 24, 2026.
EEO Statement Actalent is an equal opportunity employer.
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Pay and Benefits The pay range for this position is $50.00 - $70.00 per hour.
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.
Requirements Eligibility requirements may apply to benefits and may depend on your job classification and length of employment. For this temporary role, benefits may include medical, dental, and vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; disability; health spending account; transportation benefits; employee assistance program; and paid time off.
Application Deadline This position is anticipated to close on Apr 24, 2026.
EEO Statement Actalent is an equal opportunity employer.
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