Associate Production Scientist - D Shift
About The Position
Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001. This position primarily involves the safe and efficient manufacturing of active pharmaceutical ingredients (API’s) according to current Good Manufacturing Practice (cGMP) requirements. The role of Associate Production Scientist is a lab-based role primarily focused on supporting and executing activities in the manufacturing environment, including but not limited to: executing existing production procedures, updating supporting documents, maintaining the safety and quality of the manufacturing process, and other production tasks as directed. D shift is Thursday-Sunday 6:30pm-7:00am, then Friday-Sunday 6:30pm-7:00am
Requirements
- Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline.
- 1+ years of regulated pharmaceutical or chemical production manufacturing experience in an academic or professional setting.
Nice To Haves
- Ability to read and understand written protocols.
- Basic computer literacy (Microsoft Office and Outlook tools, Electronic Document Management Systems, etc.).
- Effective oral and written communication skills.
- Basic mathematical skills.
- Possess a high degree of motivation and self-starter attitude.
- Ability to multi-task while paying close attention to detail.
Responsibilities
- Demonstrate proper lab safety practices and comply with FDA, OSHA, EPA, DNR, DOT, and other regulatory guidelines.
- Operate as a primary operator in multiple cGMP production areas, including Kilo Labs, and train secondary operators to achieve primary status.
- Draft preliminary reports on deviations from procedures, identifying potential contributing factors.
- Utilize and update written procedures, including operation and batch records, with assistance from supervisors.
- Mentor new employees through technical and on-the-job training, fostering a collaborative team environment.
- Maintain safety and cleanliness in production areas, focusing on potent compound handling techniques and proper PPE usage.
- Communicate production status effectively using shift pass-off tools and computer systems, while addressing safety and process issues promptly.
- Take ownership of departmental responsibilities, providing support through additional tasks as directed by leadership.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
