Aseptic Processing Technician

Stokes Pharmacy•Mount Laurel Township, NJ

5d•Onsite

About The Position

This position requires an individual who can work within a cGMP environment in collaboration with other Aseptic Processing Technicians under the direct supervision of the Manufacturing Manager. The successful candidate must be focused on achieving individual and team productivity goals while maintaining a high level of precision and quality.

Requirements

Minimum high school diploma or general education degree (GED)
Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
Must be capable of working with small and large pieces of machinery
Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas)
Must be able to perform aseptic gowning and related procedures
Must possess strong verbal, written, and oral communication skills
Must be able to work independently and with a team
Must possess problem-solving skills
Ability to recognize priorities and actively make productive use of time to build operational efficiencies
Must exhibit punctuality and low absenteeism

Nice To Haves

Experience working in cleanrooms using aseptic technique is preferred
Experience in manufacturing is preferred

Responsibilities

Practice current Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP) at all times
Participate in all aspects of aseptic production (i.e. component preparation, set-up, aseptic processing, etc.) while maintaining cGMP records (e.g. batch record)
Ensure daily operations are run efficiently to maintain anticipated production output and maintain product quality for patient safety
Complete batch documentation in accordance with GDocP
Assist in the development of Standard Operating Procedures (SOP) and related cGMP processes
Assist in qualification/validation protocols for processes and equipment
Maintain room and equipment logbooks for department (i.e. controlled areas, autoclave, etc.)
Ability to troubleshoot critical manufacturing processes with appropriate communication and documentation (i.e. batch records, logbooks, and other related documentation)
Report all unusual, non-routine occurrences when performing tasks (NOE report)
Ensure personal training records are up to date and assist in training other technicians
Attend training classes, workshops, meetings, etc., as required to improve job skills and product related procedures
Work in collaboration with other members of the manufacturing team and other departments such as quality and facility maintenance to achieve company goals
Perform cleaning and maintenance of environmentally controlled areas
Abide by all company gowning requirements as well as operational requirements
Properly use all equipment (i.e. pH meters, balances, peristaltic pumps, etc.) involved in compounding and aseptic processing operations
Calibrate scales, electronic meters, etc., and document the activities in the appropriate logbook
Coordinate with Supply Chain Technicians to ensure in-stock conditions on all manufacturing materials
Demonstrates, at all times, safe work habits and maintains a safe work environment
May participate in other Manufacturing Operations as needed