Our client is a trusted FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services. The role is responsible for the preparation, manufacturing, packaging and completion of corresponding documentation of sterile drug product(s) and maintaining quality aseptic area(s) within an outsourcing facility.
- Pharmaceutical experience preferred
- Responsible for sterile drug preparation and supporting activities
- Operate all formulation, sterile filling, inspection and final vial packaging equipment
- Aseptically perform and support manual filling activities within a cleanroom environment
- Follow SOPs, product batch record instructions, and corresponding quality documentation in detail
- Prepare and maintain accurate documentation following cGMP principles
- Perform manual inspection of empty vials and filled product with a focus on quality and efficiency
- Ensure proper accountability and traceability of components, ingredients, and finished products
- Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns and areas for improvement in quality, yield and efficiency.
- Recognize inappropriate directions and/or equipment operation and notify management accordingly.
- Utilizing and handling appropriate supplies and raw materials for proper aseptic manufacturing.
- Support equipment calibration, equipment/utility validation, and preventive maintenance.
- Perform appropriate aseptic gowning and cleaning techniques.
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications.
- Adhere to all facility safety policies and procedures and proactively identify unsafe conditions.
- Be able to lift up to 50 lbs. and stand for extended periods of time when required
- Understanding of scientific formulations, aseptic techniques/environments and cGMP requirements preferred
- High school diploma or GED required
- Experience in a manufacturing environment or healthcare industry preferred
- Knowledge of materials and techniques used in sterile manufacturing, cleaning and gowning preferred
- Knowledge of and familiarity with controlled environment equipment and area(s)
- High integrity and the ability to work in changing environment
- Good interpersonal and communication skills, both verbal and written
- Willing to work extended hours, complete repetitive tasks and stand for prolonged periods of time
- Ability to work on your own or within a team environment, with good organizational skills. Detail oriented.
- 1st shift: $21.25/hour – Monday – Thursday 6am-4:30pm, Friday OT
- 2nd shift: $23.25 /hour (+ $2.00 differential) – Monday – Thursday 3:30pm – 2:00am, Friday OT