Summary

The Supervisor’s responsibilities include:

• Supervision of the inspection and labeling processes.
• Provide support in other areas such as cleaning, material transfer, restocking, and waste destruction.
• Overseeing implementation and compliance with STAQ Quality Systems (includes SOPs, WIs, etc.), continuous quality improvement activities, etc.
• Ensuring compliance with Food and Drug Administration (FDA) guidance’s.

Safety and Responsibilities

SAFETY

• Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.
• Authorized to immediately stop any task that is determined to be an imminent hazard.
• Always promote and demonstrate safe work practices and adhere to PPE requirements.
• Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift.

PRIMARY RESPONSIBILITIES:

• Supervise employees who are responsible for inspection and labeling. Position may have dotted line supervision to other areas of operations.
• Coordinate and provide training to employees in inspection, labeling, and applicable production processes.
• Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc. This includes time and attendance review and maintenance for all department employees.
• Review and assign daily line assignments to ensure production goals are achieved.
• Hire, develop and motivate manufacturing personnel. Assure continual development of staff. Conduct bi-annual performance reviews for staff. Conduct more frequent reviews for new hires and personnel who have shown performance deficiencies.
• Ensure all SOPs are current, training on SOPs, WIs and processes remains current and compliance with STAQ Quality Systems.
• Ensure staff qualifications are appropriately scheduled and maintained.
• Provide on-the-floor support to production personnel.
• Analyze Production efficiencies, downtime, and waste. Lead teams to improve results and production output.
• Write or assist with writing non-conformances that occur in the department. Work collaboratively with support departments to resolve issues and ensure production efficiency and timely batch release.
• Serve as subject matter expert in relevant CNC activities - qualified to operate, perform changeover, and perform routine maintenance activities for all labeling and visual inspection equipment.
• Demonstrates advanced troubleshooting skills and the ability to make recommendations and collaborate on solutions for resolving issues.
• Maintain production schedule tracking and batch record status updates.

Qualifications and Education Requirements

• High School Diploma or GED required.
• Minimum 5 years of general work experience.
• 1-3 years of experience in supervising a cGMP FDA regulated manufacturing environment; 2 or more years aseptic processing preferred.
• Knowledge of cGMP guidelines/standards.

Preferred Skills

• Experience with ISO Standards.
• Demonstrated effective and respectful interaction skills and a measurable track record of influence at all levels of an organization.
• Excellent organizational, leadership, motivational, analytical problem solving and strategic thinking skills.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced environment with dynamic priorities and demands.