Location: Buena, NJ
Essential Duties and Responsibilities:
- • Ensures compliance with GMP, SOPs, Quality and Safety requirements and leads coordination of activities of Packaging associates to meet daily operations requirement.
• Assures packaging batch records are reviewed, corrected and submitted to Quality Assurance.
• Ensures proper allocation of resources (permanent and temporary) for packaging in an efficient manner.
• Acts as liaison between packaging personnel and Topical Manager.
• Ensures timely communication of incidents related to Safety and Quality (process deviations/notice of events) to management.
• Actively involves in investigating process deviations, notice of events and placing appropriate corrective action and preventative actions (CAPA).
• Adhere to best practices for the department in accordance to government regulatory and quality standards while meeting department goals and objectives.
• Operate 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 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.
Education and/or Work Experience Requirements:
- • 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 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.
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.