Process Development Associate (1st Shift)
Job Responsibilities:
- Assist in the creation, development, and transfer of manufacturing processes from R&;D to manufacturing.
- Maintain and operate the Pilot Plant laboratory in compliance with cGMP (current Good Manufacturing Practices) standards.
- Produce development, pilot, and production materials per written instructions.
- Complete ERP transactions and maintain accurate inventory of laboratory supplies.
- Ensure all records and documentation are completed on time and accurately.
- Assist in the execution of process validation for new and existing manufacturing processes.
- Support continuous improvement initiatives to optimize manufacturing processes.
- Complete cycle counts and maintain proper inventory control.
- Ensure safety standards are met, including the safe handling of hazardous materials and chemicals.
- Maintain cleanliness and organization of the laboratory and workspace.
- Follow written procedures to complete laboratory tasks and associate paperwork.
Skills:
- Knowledge of cGMP and manufacturing processes.
- Familiarity with process development and validation.
- Ability to work with laboratory equipment and maintain accurate records.
- Strong problem-solving skills and attention to detail.
- Ability to lift and carry up to 40 lbs and perform tasks that may involve standing, bending, or walking.
- Comfortable working in an environment with potential exposure to hazardous chemicals or materials.
- Ability to follow written procedures and work within safety and quality standards.
Education/Experience:
- Bachelor’s degree in a scientific field (e.g., Biology, Chemistry, or related discipline).
- 1+ years of experience in a manufacturing or laboratory environment preferred.
- Familiarity with QMS (Quality Management System) and GMP regulations.
- Ability to work well independently and as part of a team.
- Excellent organizational skills and the ability to prioritize tasks.
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