Formulation Associate
redShift, Stockbridge, MA, United States
Formulation Associate I / II
Location: Near Stockbridge, MA Pay Rate: $19.58
$36.59 per hour (based on experience) Employment Type: Full-Time | Multiple Shifts Available
Position Overview
Our regulated manufacturing client is seeking skilled Formulation Associates (Level I & II) to support formulation and compounding operations within a GMP environment. This role is responsible for executing production processes, preparing solutions, and operating specialized equipment while maintaining strict adherence to quality and regulatory standards.
Working under the direction of the Formulation Supervisor, this position plays a critical role in ensuring safe, accurate, and efficient manufacturing of products while supporting continuous improvement and operational excellence.
Key Responsibilities
Formulation & Production Operations
Perform formulation and compounding activities according to SOPs, batch records, and GMP requirements
Prepare buffers, media, and other solutions following detailed instructions
Execute key process steps including API dissolution, in-process testing, and final batch preparation (QS)
Support production start-ups, changeovers, and technology transfer activities
Equipment Operation
Operate manufacturing equipment such as tanks, filtration systems, autoclaves, glass washers, and integrity testing devices
Ensure proper setup, operation, and cleaning of equipment
Troubleshoot routine equipment and process issues, escalating complex concerns as needed
Documentation & Compliance
Accurately complete batch records and documentation prior to review
Maintain logbooks and ensure compliance with cGMP, cGLP, and regulatory standards (FDA, 21 CFR 210/211/820)
Initiate and document process deviations, participate in investigations, and support corrective actions
Quality & Continuous Improvement
Ensure product quality, safety, and batch integrity at all times
Identify and communicate process improvements and operational efficiencies
Support audit readiness and maintain a high standard of compliance
Collaboration & Communication
Work closely with supervisors and team members to meet production schedules
Communicate issues, delays, or opportunities for improvement in a timely manner
Cross-train across functional areas to expand technical capabilities
Location: Near Stockbridge, MA Pay Rate: $19.58
$36.59 per hour (based on experience) Employment Type: Full-Time | Multiple Shifts Available
Position Overview
Our regulated manufacturing client is seeking skilled Formulation Associates (Level I & II) to support formulation and compounding operations within a GMP environment. This role is responsible for executing production processes, preparing solutions, and operating specialized equipment while maintaining strict adherence to quality and regulatory standards.
Working under the direction of the Formulation Supervisor, this position plays a critical role in ensuring safe, accurate, and efficient manufacturing of products while supporting continuous improvement and operational excellence.
Key Responsibilities
Formulation & Production Operations
Perform formulation and compounding activities according to SOPs, batch records, and GMP requirements
Prepare buffers, media, and other solutions following detailed instructions
Execute key process steps including API dissolution, in-process testing, and final batch preparation (QS)
Support production start-ups, changeovers, and technology transfer activities
Equipment Operation
Operate manufacturing equipment such as tanks, filtration systems, autoclaves, glass washers, and integrity testing devices
Ensure proper setup, operation, and cleaning of equipment
Troubleshoot routine equipment and process issues, escalating complex concerns as needed
Documentation & Compliance
Accurately complete batch records and documentation prior to review
Maintain logbooks and ensure compliance with cGMP, cGLP, and regulatory standards (FDA, 21 CFR 210/211/820)
Initiate and document process deviations, participate in investigations, and support corrective actions
Quality & Continuous Improvement
Ensure product quality, safety, and batch integrity at all times
Identify and communicate process improvements and operational efficiencies
Support audit readiness and maintain a high standard of compliance
Collaboration & Communication
Work closely with supervisors and team members to meet production schedules
Communicate issues, delays, or opportunities for improvement in a timely manner
Cross-train across functional areas to expand technical capabilities