Location: Buena, NJ
- Manufacturing activities such as weighing, equipment set-up, mixing, homogenization, in-line milling, product transfer and cleaning processes. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOP’s.
- Executes written SOP’s to ensure the purity of materials involved in the manufacturing process.
- Learns and executes Batch Production Record (BPR) and logbook documentation with detail and accuracy as it applies to job function in real time.
- Learns and demonstrates behaviors related to safety, quality, and production.
- Follows and adheres to all cGMPs, compliance/regulatory mandates, SOP’s and quality requirements.
- Carries out processing/department activities as required on a daily basis.
- Stage processing lines with components.
- Use a pallet truck (manual and electric).
- Identifies and communicates processing related issues to the area management.
- Works in collaboration with colleagues from the same and other departments such as quality, maintenance, and the laboratory.
- Perform general housekeeping of the manufacturing floor and work-station to maintain a clean and safe working environment.
- Other responsibilities as assigned.
- Minimum high school diploma of GED with 2- 3 years of experience working in Pharmaceutical preferably in Topical dosage form or Medical Device Industry or equivalent education and work history.
- Proficient and multi-skilled in all aspects of batch compounding of pharmaceutical products. Experience with production of creams, lotions and liquid products is preferred.
- Ability to read and understand batch record requirements and perform unit operations such as equipment set-up, chemical additions, management of heat/cool cycles, in-process sampling, and product isolation.
- Excellent understanding of cGMP regulations and ability to apply them in day-to-day work situations.
- Experience with homogenizers, in-line mills, and transfer pumps.
- Able to communicate effectively with managers and co-workers.
- Able to consistently complete batch documentation with a high level of accuracy.
- Demonstrated ability to work on minimal supervision and ability to read and understand written procedures and instructions.
- Demonstrated ability to work in a team environment with excellent communication skills.
- Demonstrated ability to perform basic math (add, subtract, multiply, divide, weights & measures).
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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.