Perform component inspections and raw material sampling processes with direct oversight.
Properly use and apply measuring devices, including but not limited to calipers, go/no-go gauges, pin gauges, scales, and rulers.
Complete daily documentation in accordance with Good Documentation Practices (GDP) for instrumentation, including scales and gauges, as well as logbooks and inspection records.
Monitor temperature and cleaning conditions of cold and hot box storage areas.
Operate and complete certification for electric and manual pallet jacks.
Properly use required PPE.Read and follow SDS and other applicable safety materials.
Apply knowledge of basic cGMPs, safety evacuation procedures, and reporting requirements.
Report safety and quality events accurately and promptly.
Follow established processes for the storage of raw materials and component retains.
Accurately operate scanners.
Identify warehouse locations and materials accurately.
Apply cGMP, safety, and continuous improvement practices to enhance customer satisfaction through accurate inspections.
Participate in other activities as assigned by Quality Management.
QUALIFICATIONS
Working knowledge of FDA regulations for drugs and/or medical devices.
Knowledge of chemical safety and proper use of protective equipment.
High School Diploma required.
Minimum of 1 year of experience in an FDA-regulated pharmaceutical or medical device environment, or an equivalent combination of education and experience.
Must be able to lift up to 25 pounds on a regular basis.
PHYSICAL/ENVIRONMENTAL DEMANDS
Ability to stand and walk for extended periods.
Ability to lift up to 30 pounds.
Exposure to chemicals and other potential workplace hazards while following established safety procedures.
Will be required to wear a full-face respirator.
QUALIFICATIONS
Education:
High School Diploma required.
A minimum of one year of experience working in an FDA-regulated pharmaceutical or medical device environment, or an equivalent combination of education and experience.
Working knowledge of FDA regulations for drugs and/or medical devices.
Knowledge of chemical safety and proper use of protective equipment.
Must be able to lift up to 25 pounds on a regular basis. EOE/ADA IND123
Review key factors to help you decide if the role fits your goals.