Location: Buena, NJ
Perform functions relating to the processing of Topical products (creams, ointments, lotions, solutions) ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements, and in conjunction with all Standard Operating Procedures (SOPs). Perform functions relating to the cleaning and sanitization of compounding process equipment and compounding facility to facilitate GMP compliance, quality, safety, and schedule attainment. Follow standard operating procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Apply skills and knowledge to recognize process issues and to increase efficiency, throughput and quality. Responsible for the safe and efficient execution of job duties.
Reporting Relationships: Individual Contributor
- 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.
- Clean and sanitize compounding Vessels, Mixers, portable and process equipment in accordance with SOPs and other regulatory / compliance guidelines.
- Execute written SOP’s to ensure the purity of materials involved in the manufacturing process.
- Learn and execute Batch Production Record (BPR) and logbook documentation with detail and accuracy as it applies to job function in real time.
- Learn and demonstrate behaviors related to safety, quality, and production.
- Follow and adhere to all cGMPs, compliance/regulatory mandates, SOP’s and quality requirements.
- Carry out processing/department activities as required on a daily basis.
- Stage processing lines with components.
- Use a pallet truck (manual and electric).
- Identify and communicate processing related issues to the area management.
- Work 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 workstation to maintain a clean and safe working environment.
- Other responsibilities as assigned.
- Minimum HS degree with preferably 2 years of experience or Associates degree with 1-year experience, working in Pharmaceutical industry or equivalent education and work history.
- Experience with all aspects of batch compounding of pharmaceutical products and with production of creams, lotions and liquid products.
- 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 preferred.
- Able to communicate effectively with managers and co-workers.
- Demonstrated ability to work on minimal supervision and ability to read and understand written procedures and instructions.
- Demonstrated ability to perform basic math (add, subtract, multiply, divide, weights & measures).
- Must be able to lift up to 50-75 lbs.
- Able to move drums of raw material which weigh 200-400 lbs.
- Wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
- Able to work in a production environment which may be dusty and contain fumes–will wear protective equipment.
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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.