Internal Applications:
Job level: 8
Currently hiring for Lead Hand III - Unit 4 - Weekend Day Shift

If you are interested in the Lead Hand III position on any shift, please upload your resume to the Internal Job Application Site no later than February 12, 2025, and include your shift preference in your application.

The Lead Hand III is accountable to the Production Supervisor for all compounding or filling manufacturing activities occurring on the shift.  This would refer to the operation of the unit, allocation of resources, execution of development and commercial batches and effective escalation of issues relating to the equipment and work areas, quality concerns or operational deficiencies. In addition, the Lead Hand III will ensure the adequate levels of supply are stocked related to the operation including gowns, operating supplies and other PPE. The Lead Hand III will be required to be familiar with various format parts, component size variations, compounding tank variations including all peripherals and product specific requirements associated with Pharma manufacturing. Main responsibilities are related to equipment operation, training, documentation, and continuous improvement to meet the Company’s objectives and in accordance with the requirements outlined in the Standard Operating Procedures and Good Manufacturers Practices.

§  Coordinates shift changeover to ensure machinery and human resources are performing/scheduled optimally. Reports any deficiencies in machinery, materials or human resources immediately to shift supervisor for timely resolution.
§  Maintain engagement with the production schedule to help proactively organize the team for future activities.
§  Acts as a subject matter expert for equipment, product and process related items.  Understands the complexity and variation of Pharma related and product specific requirements at line and drives awareness of these items to the team.
§  Supports the introduction of new processes and equipment by becoming an expert with the equipment/process.  Participates in the generation of SOPs, guidance documents and training programs to ensure information is properly cascaded through the remainder of the team.
§  Accountable to provide timely and pertinent updates to the Shift Supervisors and Managers.
§  Accountable to produce a quality product, on-time and right the first time.  Required to escalate any risks to achieving this promptly to PRD Leadership.
§  Actively participates in and supports the continuous improvement initiatives projects. Collaborates with the other supporting departments on reactive and proactive initiatives.
§  Performs the operator’s duties as necessary.
§  Ensures the availability of component and operating supplies.  Maintains guidance documents to reflect the operating supplies required for the various Pharma products/formats.
§  Reviews executed batch documents for completeness, accuracy of information and compliance with GDP.   
§  Responsible for driving corrective and preventative actions to fix documentation errors and reduce future occurrences through the training and coaching of operators.
§  Responsible to familiarize the team with document architecture and complexity of Novocol Pharma CDMO batch documents and supporting documents.  Coaches and trains the team on how to access pertinent Pharma and CDMO documents and parameters.
§  Ensures that working areas are clean and organized through the completion of routine inspections. Specific focus is paid on eliminating risks of cross contamination and damage to equipment by ensuring product dedicated equipment is stored and identified properly.
§  Initiates, investigates and rectifies Quality events by utilizing the root cause analysis and corrective action tools provided by Quality assurance.  Completes all investigation reports in a timely manner as outlined by batch release requirements.
§  Takes a leading roll in troubleshooting efforts related to equipment and resources by implementing immediate corrective action and/or involving maintenance.  Escalates equipment and personnel related issues immediately to Production Leadership to ensure the root causes are properly addressed (mechanical corrections, personnel training).
§  Participates in revision of departmental SOP’s and other GMP documents.
§  Conducts on-the-jo

Education

§  High school completion, college certification/diploma or working towards completion.

Experience

§  2 years’ experience in pharmaceutical manufacturing or a related environment. Previous leadership experience is an asset.

§  Demonstrated leadership and interpersonal skills with the ability to positively interact with interdepartmental teams.

§  Demonstrated mechanical and troubleshooting skills.

§  Ability to work independently in a varied, high pressure environment.

§  Strong communication skills, both written and verbal.

§  Flexibility to occasionally work outside of normal working hours.

§  Independence with a proactive approach to solving problems; innovative thinking and meeting challenges tenaciously with a positive attitude.

§  Proven ability to lead, execute, solve problems and achieve goals.