Production Lead (Day Shift)

The Production Lead's principal responsibilities include operating production equipment, completing associated documentation, and directing production technicians on shift on the same duties. The Production Lead is responsible for ensuring that the shift meets all safety, compliance, and performance goals while meeting production schedules. The position also coordinates with other departments such as QA, QC, Purchasing, Maintenance, and Material Control to ensure all support activities are completed in a manner that all performance goals and production schedules are met. The Production Lead will serve as the acting Production Supervisor in the absence of the Production Supervisor.

Core Responsibilities: 

• Promotes a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations.  
• Provides prompt, appropriate feedback to team members, both positive and constructive, in a continuing effort to develop employees to their full potential. 
• Demonstrates a professional and positive attitude, integrity and a strong work ethic and requires teammates to do the same.
• Effectively utilizes staff, materials, and equipment to produce quality products fit for their intended use, in a safe manner and at the optimum level of productivity to maximize business unit profitability.
• Ensures that all work by self and teammates is performed in compliance with Company SOPs, FDA CGMPs, DEA regulations and all local, state and federal regulations regarding safety, health and the environment.
• Trains staff on production activities and organizes daily work to allow for training activities to occur on time. Helps Production Supervisor track training of staff to ensure training is completed on time. 
• Ensures that both the facility and pharmaceutical systems documentation are maintained in compliance with Company and FDA/CGMP and DEA regulations and practices. 
• Facilitates problem resolution through strong working relationships with Analytical/Quality Control, Quality Assurance, Maintenance, and Material Control
• Communicates to and collaborates with the Production Supervisor employee relations issues, performance management of staff, continuous improvement, and project goals/objectives.
• Accountable for documentation and reports related to operations including, but not limited to shift handover reports, material usage reports, deviations and safety investigations.
• Ensures that waste is appropriately characterized, labelled, stored, and disposed in compliance with all Company, state and federal regulations.  
• Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately labelled with a current status tag. Works collaboratively with Maintenance, as appropriate.
• Always ensures the security and safe handling of all controlled substances. Strictly adheres to all Company and DEA regulations.
• Promptly reports all incidents in the correct manner, according to procedure and completes investigations as necessary.
• Effectively escalates issues in a timely manner regarding goals versus results.
• Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
• Ensures a level of housekeeping appropriate for a pharmaceutical manufacturer. Develop and maintain 5S areas.
• Ensures appropriate inventory levels of production supplies are maintained.
• Looks for ways to improve efficiency and productivity and reduce costs and encourages team members to do the same. Effectively communicates suggestions.
• May perform all work associated with Production Technician duties to meet Production schedules.

Qualifications: 

Required

• While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
• Able to lift 50lbs and occasionally lift and or/move more than 100 pounds using available material handling equipment.
• AA/BA or equivalent minimum 3 – 5 years of experience in STEM field or High School Diploma and/or Pharmaceutical Certification or equivalent required with 7 – 10 years experience.
• Experience working in a production Kilo-Lab and/or Plant. 
• Good mechanical aptitude and ability to provide technical guidance
• Demonstrate attention-to-detail, problem solving, and ability to multi-task.
• Good written and verbal communication.
• Demonstrate leadership skills to direct a work group.

Preferred

• Solid understanding of GMP and FDA regulations
• Prior basic production laboratory skills