West Columbia, SC Job Details 16 hours ago Qualifications Manufacturing management Quality records maintenance Packaging machines Expiration dates monitoring Machine operation Safety regulations Staff scheduling Regulatory compliance Managing production or assembly teams Employee relationship building Employee training Mid-level Manufacturing standard operating procedures Manufacturing facility experience Disciplinary action management Team development Employee attendance management Bachelor's degree Quality assurance standard operating procedures Quality inspection Compliance support tasks Production monitoring Biomedical regulatory compliance Production batch record review Quality control communication Safety standard operating procedures Standard operating procedures (SOPs) Manufacturing company experience Quality control records management Team motivation (leadership skill)
Full Job 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),
