Production Operator Lead - Full-Time - Weekend

Job Description:

The Production Operator will be a highly skilled production operator which will include ensuring that we meet the demand for products, production quality levels and production yield goals while maintaining cost control. This position will require being able to operate production equipment and perform all duties that are required within the production area. Must be a self-starter who is comfortable working in a dynamic, team-based environment to reach common objectives with aggressive schedules.

Reports to Production Supervisor of Manufacturing – Consumables.

Duties and Responsibilities:

· Works in a safe manner and follows safety rules at all times. · Ability to problem solve and communicate issues/resolutions to production management. · Understands, undertakes and implements quality control/assurance techniques and procedures. · Ability to work with minimal supervision, supports and drives process improvements and team culture. · Follows procedures to ensure production of quality product. · Generates product labels to meet production demand. · Adhere to a production schedule and ensure that materials are stocked and ready for the production day. · Inspect and ensure that all equipment is calibrated and in working order; balances/scales, pipettes, mediaclave, water purification systems, etc. · Sanitization and autoclaving of all media production equipment and areas prior to and following production work. · Performs aseptic techniques while following the SOPs. · Documents lot numbers, calibration and serial numbers of all equipment used as well as any pre-fill QC; pH, temperature, water resistivity, TOC levels, etc. · Completes batch process records and ensure they are correct and complete. · Assist with the execution and documentation of IQ/OQ and PQ processes. · Maintain and post Manufacturing metrics. · Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and directives. · Support immediate supervisor and peers by anticipating problems, providing input on solutions, reacting productively to change and handling other tasks as assigned. · All other duties assigned by Supervisor.

Qualifications/Experience:

· HS diploma and 2 years’ experience or Associates degree. · Experience with automated manufacturing processes is a plus. · Ability to perform simple maintenance and troubleshoot automated equipment a plus. · At least 1 year of cleanroom experience required. · Excellent aseptic process/laboratory skills. · Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus. · Ability to adhere to a production schedule.

· Requires the ability to multi-task and maintain focus. · Ability to accurately write and follow procedures. · Must be able to communicate in English with others related to daily operations. · Good problem solving, math skills and ability to do mathematical conversions (Metric to English). · Ability to use computers for required business functions. · Understanding and willingness to implement 5S and lean manufacturing techniques. · Performs repetitive workstation assembly to produce manufacturing sub-assemblies, including interpreting drawings and following SOPs.
· High degree of accuracy.

Working Conditions:

· Appropriate gowning procedures will be required (hairnet, safety glasses, clean room apparel/lab coats, latex gloves) · Occasional environmental odors may be prevalent · May be required to work extended hours and weekends · Must be able to lift 50 pounds · Must be able to work standing for prolonged periods of time.

Work safely and follow all safety rules at all times. Solve problems and communicate issues and resolutions to production management. Learn to troubleshoot production systems. Lead up to 15 employees with patience and professionalism. Manage the PHR review and correction process, ensuring GMP is followed. Maintain an up-to-date Preventive Maintenance schedule. Lead the shift, overseeing attendance, break coverage, emergencies and evacuations, personnel performance and production issue reporting, and interdepartmental communication. Communicate effectively with senior management. Serve as the primary point of contact for receiving and communicating shift pass-downs. Hold team members accountable for meeting production targets. Develop team members’ technical and leadership skills. Work with minimal supervision while supporting and driving process improvements and team culture. Ensure materials are stocked, kitted, and prepared for the production day. Process transactions in SAP daily. Perform shift startups and shutdowns. Perform other duties as assigned by the Manager.

High school diploma with 2+ years of experience, or an Associate’s degree. Strong verbal and written communication skills, sufficient to manage cGMP documentation practices. Ability to lead and manage team dynamics, including conflict, motivation, and engagement. Excellent aseptic process and laboratory skills. Ability to adhere to a production schedule. Ability to work overtime, including off-schedule shifts and periodic weekends. Basic computer skills, including working knowledge of Microsoft Office. Commitment to updating work processes and driving continuous improvement.