Secondary Packaging Supervisor

NEPHRON SC, LLC•West Columbia, SC

7d•Onsite

About The Position

Oversees the production machine operations while assisting with additional duties and responsibilities as needed or required, and performs other tasks as assigned or apparent. This role involves ensuring product lines run within time guidelines for changeovers, with correct lot# and expiration date, formulations, clean in place and product transfer. It also requires verifying all Batch Records and Lot Records are complete to meet GMP requirements, including all required signatures and/or initials. The position is responsible for the training of new hires and personnel involved in cross-training, monitoring employee attendance/tardiness, and providing guidance and discipline when appropriate. Additionally, the supervisor monitors timecards, vacations, and personal time to ensure adequate staffing for production lines to meet requirements. Administrative duties include personnel roster, personnel scheduling, and monitoring production lines. The role also assists with monitoring all production areas and personnel for adherence to cGMP, SOPs, and safety regulations, and aids in developing solutions for chronic quality assurance problems. Communication of quality-related observations, issues, problems, discrepancies, and violations of company policies to Quality Management is essential. Adherence to cGMPs is required at all times, with all personnel owning the quality of their output and being responsible for timely notification of regulatory inspections, GMP deficiencies, process deviations, product defects, and related actions. The supervisor must stay abreast of current FDA requirements and ensure compliance through familiarity with department SOPs and routine observance of procedures. Assistance in other Quality Assurance management activities is also required.

Requirements

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.
Previous manufacturing / production work experience preferred.

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.
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.