Supervisor, 503B Training And Education

Corporate Statement

Nephron Outsourcing Facility is a 503B outsourcing facility dedicated to creating the highest quality compounds by maintaining current good manufacturing practices to and above the standards set by the FDA.

Position Summary:

The Supervisor, 503B Training and Education plays a critical role in ensuring the safe and efficient operation of sterile filling processes in Nephron Pharmaceuticals Manufacturing Facility. The role is responsible for developing, implementing, and overseeing training programs and onboarding for personnel involved in sterile filling operations. The Supervisor, 503B Training and Education will work closely with cross-functional teams to ensure compliance with regulatory requirements, maintain a culture of safety, and enhance the skills and knowledge of manufacturing staff.

· Employ various teaching methods to ensure that different learning styles are represented during the training process

· Implement training programs for personnel involved in sterile filling operations, ensuring alignment with industry best practices and regulatory guidelines.

· Maintain a comprehensive training curriculum that covers a range of topics, including aseptic techniques, equipment operation, quality standards, and safety protocols.

· Maintain accurate and up-to-date training records for all personnel, tracking progress and completion of training requirements.

· Continuously audit and reinforce standards, expectations and procedural compliance

· Evaluate the performance of sterile filling technicians and provide feedback on their skills and knowledge

· Ensure compliance with all regulatory requirements

· Collaborate with other departments to ensure that training is aligned with the company’s overall goals and objectives

• Perform On-the-Job (OJT), group and one-on-one trainings with sterile filling technician personnel
• Contact and coordinate with different departments and resources for task specific trainings
• Prepare training timelines and provide regular training status updates to management
• Maintain database for completed and in-progress training
• Routinely review employee errors for training effectiveness

· Required to enter cleanroom as needed to observe aseptic technique. Make corrections and conduct re-trainings if deemed necessary

• Evaluate and communicate training needs to upper management
• Assist with and lead personnel media fills when needed

· Provide support for the initial onboarding and training of new hire sterile filling technicians into the 503B Production Department

· Ensure each sterile filling technician training folders are maintained and up to date

· Seek feedback from Sterile Filling Technician staff on areas of developmental need and works to provide continuous educational and professional development needs

· Assists in appropriate training, education, and competency assessment plans to address needs

· Coach pharmacy technicians in career growth professionally

· Performs all other duties as assigned or apparent.

· Required to uphold a media fill certification to assist in operations when needed.

Primary Accountabilities:

• Must have extensive knowledge of automated and manual production filling processes.

· Develop and conduct trainings to support reinforcement of standards and consistency in behaviors across all shifts.

• Establish a constructive learning environment and relationship with the trainee to encourage advice-seeking and maximize learning opportunities.
• Provide regular feedback of trainee’s progress including achievements; identify any areas for improvement as early as possible. Take appropriate steps to facilitate improvement in performance or recommend other actions as necessary.

· Continuously audit and reinforce standards, expectations, and procedural compliance on the production floor. Serve as a mentor and example for personnel.

• Assist with production needs as necessary based on production schedule.

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and knowledge, skills and abilities are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

· Associates or Bachelors degree preferred, or relevant experience in Pharmaceutical Manufacturing

• Must be a registered pharmacy technician
• Familiarity with Lean or Six Sigma methodologies
• Previous training experience preferred.
• Strong understanding of aseptic techniques, cGMP, and regulatory requirements.
• Computer experience: Excel, Word

· MUST PASS DRUG TEST!!!!

· Must speak, write, and read English.

· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands in a fast-paced environment.

· The ability to create and contribute to an environment that values safety, people, encourages trust, teamwork, open communication, and provides participation, learning, feedback and recognition.

· The ability to effectively manage one self, demonstrate integrity, be productive under pressure, and achieve development goals

· The ability to manage a multitude of resources and to be accurate and current with data and information.

· Position requires lifting (up to 60 lbs.), vision (20/20), bending (waist to floor), climbing (floor to ceiling), reaching (floor to overhead), standing (75%), sitting (5%), walking (20%), gripping, talking and hearing.

· Incumbents are required to wear PPE as assigned by management.

· Incumbents are required to comply with proper gowning requirements and other non-specified protective equipment as necessary.

· Incumbents may be required to wear safety glasses, hearing protection, bouffant, and laboratory coats and other non-specified protective equipment as necessary.

• Salary range: Based on experience

· Hours of Work: As required by management. Must have schedule flexibility to support all shifts.

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.