Location: Buena, NJ
Responsible for providing direction and training to the compounding team ensuring manufacturing compliance to established current Good Manufacturing Practices (cGMPs), batch requirements and in conjunction with all Standard Operating Procedures (SOPs). Applies skills and knowledge to recognize process issues and to increase efficiency, throughput and quality. Troubleshoots process, equipment issues and, as a team member, analyzes root causes and makes recommendations. Provides ongoing training to the compounding team.
Reporting Relationships: Up to 10 direct reports
- Ensures compliance with GMP, SOPs, Quality and Safety requirements and leads coordination of activities of Compounders to ensure successful completion of batches.
- Assures manufacturing batch records are reviewed, corrected and submitted to Quality Assurance by the required deadline.
- Ensures timely communication of incidents related to Safety and Quality (process deviations/notice of events) to management.
- Actively involved in investigating process deviations, notice of events and placing appropriate corrective action and preventative actions (CAPA).
- Adheres to best practices for the department in accordance to government regulatory and quality standards while meeting department goals and objectives.
- Operates compounding machinery which include start-up, equipment set-up, filling, changeover, cleaning and sanitization as needed.
- Ensures all compounding operators are trained on and execute written SOP’s to ensure the purity of materials involved in the compounding process.
- Ensures Batch Production Record (BPR) and logbook documentation with detail and accuracy as it applies to job function in real time.
- Identifies and communicates processing related issues to the area management.
- Train compounding new hires on training modules to ensure basic understanding of the batching process and adherence to GMPs.
- Provide ongoing training to compounding team as needed. Is a team player and a leader with a strong focus on quality and efficiency.
- Other duties as assigned.
- Minimum high school diploma or GED with a minimum of 7 years of experience working in a Pharmaceutical environment. (Preferably in filling of topical dosage form).
- 3+ years manufacturing training experience.
- Demonstrated ability to work with minimal supervision and the ability to read and understand written procedures and instructions.
- Demonstrate mechanical ability to perform equipment adjustments and troubleshooting.
- 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).
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.