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Supervisor, Production

3 months ago

Devens, United States Bio-techne Full time

**By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.**

**Bio-Techne’s Diagnostic Reagents Division has been providing essential products to the in vitro diagnostics industry for over 40 years. We supply quality controls and reagents for clinical laboratory and point-of-care testing, along with custom products to other companies serving the IVD market.**

**Position Summary**:
The Supervisor is responsible for coordinating and supervising the manufacturing workload and ensuring that adequate resources are available to meet production schedule and demands. This position will ensure that all operations and personnel are in compliance with FDA regulations and cGMP guidelines while assuring high product quality and productivity. The Supervisor will ensure that all direct reports are fully trained, provide strong leadership, and communicate performance expectations to those direct reports. Seek and drive continuous improvement on processes and equipment.

**Principle Responsibilities**:
Leadership:

- Coordinate and supervise workload to meet schedule and customer-required ship dates.
- Drive continuous improvement in processes, procedures, production output, and quality.
- Maintain a safe and neat work environment.
- Provide training to employees on department SOP, QSR/GMP, ISO and other procedures.
- Communicate clear expectations of individual and team performance.
- Troubleshoot problems, technical and employee-related, that develop on the floor and escalate to Manufacturing Management as required.
- Develop clear objectives for all employees that are aligned with Department objectives.

Documentation:

- Possess a strong working knowledge of all Departmental procedures.
- Perform completion and verification of documentation, including reconciliation of materials.
- Initiate as needed the creation of new procedures and the modification of existing procedures.
- Initiate NCMR and ECO documentation as required.
- Work with other supervisors and team leaders to collect and publish data for key manufacturing metrics.

Equipment:

- Oversee and support equipment operators.
- Operate equipment as required to meet production schedule.
- Strong mechanical aptitude to troubleshoot and repair automated equipment, as needed.

**General Responsibilities**:

- Communicate with the Manufacturing Manager to coordinate activities with other groups such as Materials, Planning, QC, Maintenance and Warehouse.
- Coordinate production support priorities with Scheduling, Engineering, Materials, and Quality
- Execute daily quality and delivery requirements as prioritized by planning and operations management teams.
- Optimize procedures and processes for productivity and quality.
- Approve timecards and requests for vacation and personal time.
- Collaborate with Production Management for the completion of performance evaluations.
- Perform other duties as may be assigned from time to time, including assisting other departments.
- Be a Stewart for continual ISO Quality Compliance
- Enable good documentation practices and support the ISO Quality System
- Assure production team adherence to all related company Standard Operating Procedures (SOP)
- Assist in resolving any process-related issues and non-conformances, corrective actions.
- Promote cross-training to mitigate single point failures, and production surge.
- Maintain accurate training records.
- Promote the safe and efficient operation of all equipment in order to achieve quality and conformity of products.
- Display technical and personnel leadership skills; act as a role model, maintain morale and good communication.
- Communicate clear expectations to the team and provide coaching to individual team members.
- Act as backup for the Manufacturing Manager in operational review meetings and provide details reports on production status, backlog, and staffing needs as requested.
- Flexibility in work hours and ability work weekends during peak production periods to oversee the team and meet high product demand.

**Qualifications**:

- Relevant Associates degree preferred
- 5+ years’ experience supervising a manufacturing team, preferably biotech devices.
- 5+ years’ experience working in a manufacturing assembly environment, and familiar with workflow, GMP GDP and ISO regulations.
- Demonstrated training in supervisory skills, additional leadership training is preferred.
- Working knowledge of ISO9001 / ISO13485 and/or regulatory compliance requirements
- Formal continuous improvement training and experience highly desirable (Lean/ Six Sigma).
- Excellent verbal and written communication skills are required. Bilingual skills are a plus.
- Proven ability to lead and motivate individuals and teams and to work independently is essential.
- Good organizational skills with attention to detail.

**Minimum Physical Requirements**:

-