Production Shift Supervisor - Second Shift

Harrow, Inc.•Roxbury Township, NJ

5d•Onsite

About The Position

The Production Supervisor directly leads the Operations activities in the Production area and oversees direct reports. The Production Supervisor ensures manufacturing, filling, inspection, packaging, and labeling jobs are executed accurately with the highest quality, meet applicable cGMP requirements, and are completed on time per the production schedule. The Production Supervisor works with the highest degree of accountability and customer service to promptly ensure client needs are met.

Requirements

High School diploma required; Bachelor’s degree preferred.
Must have 3 - 5 years of leadership experience in a cGMP-regulated environment and have worked in a pharmaceutical, Biotechnology, or medical device manufacturing facility.
Minimum of 3 - 5 years experience in pharmaceutical manufacturing or medical device, preferably in a sterile environment.
Ability and willingness to work and participate effectively in a team environment.
Ability and willingness to maintain accurate and factual hard copy and electronic records.
Attention to detail, safety, quality, and customer requirements.
Ability to communicate effectively verbally and in writing to subordinates, peers, and management.
Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps.
Demonstrate a high level of personal motivation and initiative.

Responsibilities

Provides overall Leadership to the Sterile Production Team structured around:
Leads Production team members by providing them with strategic vision and direction aligned with Organization’s core values.
Integrates and drives collaboration within the Sterile Production area to achieve the highest levels of quality.
Fosters and drives collaboration within the production area for improvements, resulting in high-quality products and customer satisfaction.
Drives, implements, and sustains changes to attain the highest performance standards.
Facilitates communication and drives accountability.
Provides a work environment that fosters positive energy, creativity, and teamwork.
Must be able to review and approve production batch records promptly.
Must be gown qualified to supervise production in the clean room.
Supervise a one-shift operation by spending at least 50% of available time interfacing with employees to ensure that all batches are of high quality and exceed all the Company’s current Good Manufacturing Practices (CGMPs) and follow all safety guidelines.
Ensure that the production schedule is met by distributing workload following changing priorities by working in collaboration with the Quality, Supply Chain, MS & T, and Maintenance departments.
Ensure sterile production operations are appropriately controlled, regulatory compliance requirements are met by ensuring accurate batch documentation, and Standard Operating Procedures (SOPs) are proper. Personnel training is current, critical documentation templates are exact, equipment is in good repair and current calibration, and high housekeeping standards are maintained in all areas of responsibility.
Provide feedback for continuous improvement. Assist with hiring and disciplining staff, as required. Support the Company’s safety program to maximize safety awareness and provide a safe work environment.
Evaluate /solve production problems by reviewing the area of concern, developing potential solutions, technically evaluating or testing the answers, and preparing summary reports/recommendations for management.
Supports continuous improvement by completing work on time, identifying potential issues, and driving to improve work processes and procedures relative to manufacturing and/or filling and packaging equipment.
Write investigations and CAPAs for non-conformances and deviations generated by the production departments. Write and maintain SOPs and other manufacturing specifications.
Develop and Monitor KPIs to improve department metrics, including scrap, non-conformance, batch record errors, and plant efficiencies.
Other additional duties as assigned.