Location: Buena, NJ
- Adhere to best practices for the department in accordance to government regulatory and quality standards while meeting department goals and objectives.
- Operate filling and packaging machinery which include start-up, equipment set-up, filling, changeover, cleaning and sanitization.
- Execute written SOP’s to ensure the purity of materials involved in the filling and packaging process.
- Demonstrate mechanical ability to perform equipment adjustments and troubleshooting.
- Batch Production Record (BPR) and logbook documentation with detail and accuracy as it applies to job function in real time.
- Demonstrate behaviors related to safety, quality, and production.
- Follow and adhere to all cGMPs, compliance/regulatory mandates, SOP’s and quality requirements.
- Identify and communicate processing related issues to the area management.
- Collaborate with colleagues from the same and other departments such as manufacturing, quality, maintenance, and the laboratory.
- Other duties as assigned.
- Minimum high school diploma or GED with a minimum of 2 to 3 years of experience working in a Pharmaceutical environment. (Preferably in filling of topical dosage form).
- Demonstrated ability to work with minimal supervision and the ability to read and understand written procedures and instructions.
- Demonstrated ability to work in a team environment with excellent communication skills.
- Experience in a clean room environment and best practices.
- Demonstrated ability to perform basic math (add, subtract, multiply, divide, weights & measures).
While performing the duties of this job, the employee is regularly required to:
- Talk and hear.
- Stand and use cleaning and sanitization chemicals (LpH, Vesphene, Vesta-Syde, Spor-klenz, Sodium Hypochlorite solution, etc.), as part of the daily cleaning/sanitization duties.
- Must be able to wear a PAPR and a Full-face respirator as part of the Cleanroom Services daily duties.
- Must occasionally lift and/or move up to 40 pounds.
- Frequently required to visually inspect product and must have the ability to see clearly at close vision (20 inches or less) and at a distance of 20 feet or more (20/20 corrected vision.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.