Description
Job Purpose:
Oversees the production machine operations while assisting with additional duties and responsibilities as needed or required, and performs other tasks as assigned or apparent.
Essential Duties and Responsibilities:
- Communication to/from peers via production log book, and face-to-face communication with on coming/off-going supervisor.
- Ensure product lines are running within time guidelines for changeovers, with correct lot# and expiration date, formulations, clean in place and product transfer.
- Verify all Batch Records and Lot Records are complete to meet GMP requirements to include all required signatures and or initials.
- Ensure training of new hires and any personnel involved in cross training.
- Monitor employee attendance/tardiness and provide guidance and discipline when appropriate, monitor timecards, vacations, personal time, etc., to ensure production lines are staffed in order to meet the production requirements.
- Perform administrative duties to include personnel roster, personnel scheduling, and monitoring production line.
- Supplemental Functions:
- Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
- Assist with development of solutions for chronic problems within quality assurance
- Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
- Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
- Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
- Assist in other activities (as needed) for Quality Assurance management.
Job Specifications and Qualifications:
Knowledge & Skills:
- Previous experience with B/F/S or Packaging equipment a plus
- Detail oriented, ability to work independently as a self-started, dependable and ability to supervise and motivate up to twenty to seventy employees.
- Previous supervisory training preferred.
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
- The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
- The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
- The ability to manage a multitude of resources and to be accurate and current with data and information.
Education/Experience:
- Bachelor's degree or 5+ years equivalent experience
- Previous manufacturing / production work experience preferred.
Working Conditions / Physical Requirements:
Position requires reaching (waist to overhead), bending (waist to floor), climbing (floor to ceiling), lifting (up to 20 lbs), vision (20/20), good hearing, standing (30% of shift time),