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
Qualifications
Formulation Associate I:
- 0-2 years of experience in a GMP or regulated manufacturing environment
- Associate degree in a science-related field or equivalent experience
Formulation Associate II:
- 3-4 years of experience in GMP formulation or compounding operations
- Bachelor's degree in a science-related discipline or equivalent experience
General Requirements:
- Working knowledge of formulation/compounding processes and equipment
- Strong attention to detail and commitment to quality
- Familiarity with cGMP and regulatory requirements
- Basic computer proficiency (Microsoft Office and related systems)
- Strong communication and teamwork skills
- Ability to prioritize tasks and manage multiple responsibilities
Physical & Work Requirements
- Ability to work in a shift-based, 24/7 production environment
- Ability to stand or remain stationary for extended periods
- Ability to lift up to 30 pounds repeatedly
- Ability to wear required personal protective equipment (PPE)
- Must meet gowning and cleanroom requirements
- Adequate visual acuity and motor skills to operate equipment and handle materials
- Must be medically qualified to participate in a respirator program
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