Job description
Duties and Responsibilities:
PHYSICAL REQUIREMENTS:
- Understands current processes and identify opportunities for improvement, including conducting interviews, observing technicians, collecting data, trending data and analyzing data for improvement.
- Performs regular audits of production processes and helps implement lean six sigma manufacturing principles (5S, OSW/SWIs, Gemba, etc.)
- Develops and maintains Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs) and Forms used in both sterile and non-sterile compounding operations.
- Work in close collaboration with training and production to develop a robust training program on new processes.
- Collaborates with Quality to maintain alignment of manufacturing systems processes with all quality system requirements to improve overall quality of the product.
- Identifies areas of waste and improves efficiencies and develop strategies to reduce or eliminate it.
- Improves visibility of KPI’s reporting, and development improvement actions based on KPI analysis.
- Collaborates with R&D for downstream processing development activities and optimization of manufacturing processes including formulation. Assist if required in the development/optimization of upstream manufacturing processes.
- Serves as the SME for details of each specific operation they are supporting
- Provides support to facilitate closure and completion of investigations, deviations and CAPAs (Corrective and Preventative Actions).
- Works closely with quality and engineering teams to help implement new devices, equipment, and processes into production.
- Works with the production team to identify areas for process improvement and implement changes to increase efficiency, reduce waste, and improve product quality.
- Complies with required PPE while utilizing aseptic technique and minimizing contamination.
- Works with cross functional departments to assist in the closure of NCI’s (non-conformance incidents).
- Adapts to and assumes unforeseen responsibilities as the company requires.
- Performs other duties as assigned.
Education and Experience requirements:
- Bachelor's degree in STEM (science, technology, engineering or math), life sciences related field, or equivalent experience in pharmaceutical manufacturing.
- Minimum of 3 years of experience in a pharmaceutical environment, preferably in a 503A compounding pharmacy setting.
- Strong understanding of USP 795, 797, and 800 guidelines and 503A regulations.
- Experience with aseptic techniques and cleanroom operations.
- Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices.
- Strong cGMP (current Good Manufacturing Practices), aseptic processing, and USP 797/800 background. US Pharmacopeia (USP) 795, 797, 800 and/or cGMP compliance.
- Ability to operate manufacturing equipment and perform various manufacturing processes such as a vial washer, depyrogenation tunnel and semi-automated filling line.
- Excellent attention to detail and ability to maintain accurate records.
- Strong problem-solving and communication skills.
- Ability to work independently as well as part of a team.
- Willingness to work flexible hours as needed.
- Communicate effectively both verbally and written with personnel at all levels in a professional manner.
- Excellent computer skills in MS Office (Excel, Word, PowerPoint).
- Familiarity with ERP systems.
- Must be able to gown into cleanroom (daily if needed) and pass media fill tests bi-annually.
CERTIFICATES, LICENSES, REGISTRATIONS
- Pharmacy technician trainee or certification required
- IV Certification highly preferred
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
PHYSICAL REQUIREMENTS:
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.
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