Supervisor, Inspection & Packaging (Afternoon Shift)

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Supervisor, Inspection & Packaging is responsible for daily coordination and execution of working schedules of people and equipment in inspection & packaging. Responsible for supervising hourly union operators that inspect and package a variety of drug and biological products, including Par branded, development and generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Modifies department standard operating procedures, investigates excursions, and executes change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives.

In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Supervisor of Inspection and Packaging operations at Rochester, MI manufacturing plant; Supervises 10-15 hourly workers. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.  Significant equipment includes: Inspection Tables (manual and semi-automated), Automated Inspection (Eisai), Labelers, Vision Systems, Cartoners, and Serialization equipment.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Operations

• Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
• Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization                                                                                                                                                                                                                                                                               
• Responsive to changes in daily workflow and schedule; determines needs  and redeploys resources and/or overtime  to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.
• Ensure all equipment is working properly
• Completes final batch record reviews for Inspection and Packaging
• Completes in-process checks and verifications in alignment with Standard Operating Procedures

20%

Compliance

• Understands and adheres to Good Documentation Practices (GDP)
• Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
• Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
• Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
• Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
• Approves maximo work orders

• Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
• Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
• Follow and comply with company Safety policies and OSHA Regulations

• Participates in development and maintenance of a safe manufacturing environment.  Establishes methods in compliance with regulatory, plant, and corp