Title:  Supervisor, 2nd Shift Routine Testing

Job Summary

In this role, you will be responsible for managing the day-to-day operations of the 2nd Shift GMP testing group and initiatives. Supervise the team to assure safety and conformity with processes and procedures to reduce risks and improve compliance and productivity. Monitor and achieve team metrics, provide direction to analysts, and manage their performance.

Essential Duties and Responsibilities

• Supervise the day-to-day activities which includes resource management (labor, materials, equipment, etc.), Deviation Management, Due date compliance, Time Tracking Compliance, Performance Reviews. Mentor team.
• Work directly with 1st shift management to ensure communication and cohesion of testing activities, instrumentation troubleshooting, and alignment. This is fundamental to the responsibility of the 2nd shift supervisor
• Knowledge and understanding of the following techniques and capabilities: Container closure integrity testing (including Helium leak, Vacuum Decay, headspace, Dye Ingress, USP 382), Particle testing (Clemex, ISO Cleanroom requirements, Light Obscuration, Microscopy), HPLC/GC/IC, Routine P&P testing, Method validation and Instrument qualifications
• Assist 2nd Shift, CCI and P&P Manager with management and allocation of resources and assignments
• Assure that analysts have been adequately trained for their role
• Review and release final reporting to internal and external customers as it pertains to the group. Communicate updates for all projects timely
• Follow required cGMP regulations and assure compliance per internal QA procedures
• Supervise and approve laboratory quality investigations to support internal and external customers 
• Manage the development and validation of numerous analytical techniques
• Implement continuous improvement/lean activities and events for the group
• Write, review, and approve documents (Investigations, Work Instructions, SOP’s, etc.)
• Support internal and external audits
• Hire new employees ensuring that their qualification and skills set fit with the needs of the individual role
• Independently drive projects from initiation through completion
• Lead communication with internal and external customers
• Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity
• Assure Safety procedures are followed and identify any safety risks with preventative action
• Maintain cognizance of current validation requirements.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Other duties as assigned

Additional Responsibilities

• Lead executive and technical parts of projects/ programs related to the implementation of new technologies.
• Guiding or technically supporting customer audits in the testing laboratory area.
• Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues.
• Always complies with the company’s safety and quality policies, including proper handling of biohazard materials and components.

Education

• Bachelor’s degree or equivalent experience in chemistry or closely related field

Work Experience

• Minimum 5 Years of experience of management experience, GMP testing, analytical testing and instrumentation

Preferred Knowledge, Skills and Abilities

• Awareness and understanding of the following (all skills not mandatory but preferred):
  •  Particle Testing (Clemex)
  •  Container closure integrity
  •  Product and Performance (Physicals) testing
  •  HPLC/GC/IC
  •  Method development and validation
  •  cGMP, FDA, ISO etc. regulations and requirements
  •  Basic statistical analysis.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Able to follow directions, prioritize tasks, and work independently.
• Must have excellent interpersonal, written and verbal communication skills.
• Must be proficient in Microsoft Office tools and capable to learn other software programs.
• Able to review regulatory code and learn safety standards.
• Occasionally come in earlier than their normal evening start time

Additional Requirements

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions as required.
• Handling of biohazard material and components. #LI-JJ1

Travel Requirements

Physical Requirements

Shift

Working hours are approximately Monday-Friday 2pm-10pm daily