This position reports directly to Production Management or a designated Site Manager, as assigned. 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.
Responsible for sterile drug preparation and supporting activities including:
- 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.
- Clean and disinfect cleanrooms, equipment, and supplies in support of routine production.
- 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.
- Other duties as assigned.
- Be able to lift up to 50 lbs. and stand for extended periods of time when required.
EXPERIENCE AND NECESSARY SKILLS:
- Ability to read, write, and comprehend English
- 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.
- Certification of recent (less than one year) eye exam with minimum 20/30 vision