The Operations Supervisor will oversee second shift activities for all operations occurring on the second shift. Responsible to ensure the production processes support operations deliver maximum quality in a safe and efficient manner. Monitors all activities of their direct reports (production), organizing assignment to effectively meet schedule demand. Control all activities in a fast-paced production environment, optimizing day-to-day operations while minimizing costs. Creates an engaged work environment, coaching and counselling personnel to reach their maximum potential. Prepares, reviews and revises SOPs, URSs, Work Instructions, validation documents. Considered the authority in charge for Second Shift operations.
This is a second shift position. Hours are 2 PM to 10:30 PM, Monday through Friday. Start and end times may shift due to needs of production support.
Essential Job Functions/Responsibilities
- Sets daily/weekly/monthly objectives and communicate them to direct reports
- Organizes shift workflow by assigning responsibilities and overseeing activities
- Responsible for all personnel performing operations on Second Shift
- Work in an Aseptic environment, qualifying in full aseptic gowning requirements
- Performs/ensures investigations and document corrections/modifications are done effectively and in a timely manner
- Sets high expectations for Quality, Productivity and Delivery; create and maintain a Safety culture that delivers injury and incident free operations
- Provide oversight and support to ensure adequate quality improvement initiatives are appropriately identified and implemented in a timely manner
- Maximize production output and labor efficiency while meeting safety and quality targets
- Monitors and controls production schedules and activities to ensure the meeting of departmental performance objectives and budgets.
- Create and support departmental Lean and continuous improvement initiatives
- Create metrics/reports to monitor production output according to planned expectations
- Train new employees on departmental SOPs and equipment operation
- Enforce strict safety guidelines and company standards
- Ensure operations are cGMP compliant
- Perform reconciliations of components, drug products, and associated materials as per defined procedures
- Writes, reviews and revises SOP’s for manufacturing operations
- Develops employees through orientation, training, setting expectations, communication of rules and policies while building a culture of employee engagement
- Other projects as may be assigned.
Required Education and Qualifications
- Proven experience, 2-5 years, as a Production Supervisor or similar role, preferably in the Pharmaceutical or a cGMP/FDA regulated industry
- Minimum 2-year Degree in a technical, engineering or relevant field is preferred
- Experience working in Clean Room/Sterile manufacturing environment a plus
- Able to become ‘Gown Qualified’ to work in an Aseptic environment
- Self-motivated with a team results-driven approach
- Experience in preparing SOPs, Work Instructions, and Validation documentation
- Knowledge of Lean Manufacturing/Visual Workplace a plus
- Excellent communication and interpersonal skills
- Superior problem-solving, root cause analysis skills
- Experienced in formulation, filling and packaging of sterile liquids, powders, creams and ointments. Exposure to support functions a plus (warehouse, Quality Assurance, etc)
- Advanced skills in MS Office applications (Word, Excel, PowerPoint, etc.)
- Strong organizational and leadership abilities
- Proven results in implementing process improvements and an engaged safety culture
- Searches for the most creative and innovative solutions while maintaining the highest levels of quality and productivity
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.