Secondary Packaging Supervisor Shift 3 (6pm-6:30am)

Nephron Pharmaceuticals

Description:

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.

Requirements:

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)

PI284211049