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ClorDiSys Operations Manager

Allentown, Inc.

Location Pin Icon
Branchburg, NJ
LOCATION
Multiple Shifts
SHIFT

Job Description

As posted by the hiring company

Job Overview:

JOB SUMMARY

 

Leads a team of skilled associates engaged in various aspects of processing, maintenance, and warehousing functions in contract sterilization. The role has authority and accountability to select, train and direct their workforce. Ensure key company processes are effective and efficient to achieve results and employee engagement, assuring a safe and positive team culture and environment in an FDA regulated industry.

 

Reporting to VP Operations, the Operations Manager ensures maximum utilization of equipment and overseas or performs the scheduling and processing of products consistent with the customers' time and expectations and quality requirements for multiple shifts. The role will supervise Operators, Material Handlers, and shipping/receiving staff. Ensures that all product flow, documentation, and safety protocols are maintained in compliance with the standard operating procedures (SOPs) and applicable standards (ISO 13485 and 21 CFR Part 820).

 

PRIMARY FUNCTIONS

 

  1. Ensure that all product runs are scheduled and run in a manner consistent with the customers' turn-time, SOPs and quality management system requirements.
  2. Maintains proper segregation of processed and non-processed product at all times.
  3. Coordinates downtime for preventative maintenance with the Maintenance Department
  4. Reviews and approve all final processing data prior to certification to ensure that process parameters or loading patterns are in compliance with customer specifications.
  5. Verify that all instrumentation has been calibrated before use.
  6. Prepares month end report that details system performance.
  7. Support CAPA investigations, non-conformance reviews and change control activities related to process deviations or operational failures.
  8. Maintain knowledge of relevant cGMP, Sterilization, EPA and OSHA regulations
  9. Identify opportunities for cycle optimization, waste reduction and efficiency improvements.
  10. Support customer audits, regulatory inspections, and client communication regarding processing schedules and quality concerns
  11. Provides direction and support for the operators, routine feedback on performance issues and information pertaining to the operation.
  12. Maintains and assures proper documentation and adherence to requirements including:
     • Physical counts
     • Product segregation
     • Palletizing patterns 
     • Special handling requirements
     • Damage reports
     • Company procedures and logs.
  13. Responsible for receiving and shipping in accordance with site SOP’s
  14. Reviews and approves weekly payroll hours.
  15. Responsible for the training of all operations employees
  16. Assists with other tasks and special projects as assigned by the VP Operations

 

OPERATIONS LEADERSHIP

  • Develops a shop floor culture that focuses on the achievement of the businesses’ objectives in Safety, Quality, Delivery and Cost (SQCD) by continuously focusing on waste elimination and following standard work.
  • Leads daily SQDC board meetings, trains and develops employees to meet expectations, ensures the working environment is safe through direct monitoring of behavior and equipment, incident response, mitigation, and investigation as issues occur during the shift, and providing individual and group feedback on successes and opportunities to improve performance.
  • Identify opportunities for countermeasures and participate in facility lean committees. 
  • Supports the company’s Lean business initiatives, through participation in Kaizen events, generation of Ideas and implementation.
  • First point of contact for mitigation and investigation of issues related to safety, quality, delivery, and cost.

 

PEOPLE LEADERSHIP

  • Drives employee engagement by implementing and using Lean processes.
  • Creates an environment of positive employee relations by creating a safe and productive work environment, listening to, and addressing employee concerns, assuring company policy, and constructively managing employee performance.
  • Interviewing and selection of new employees; assures the team has necessary skills and tools to complete work, ensures that shifts are properly staffed, assigns daily work to achieve Customer objectives. 

 

DELIVERY RESULTS

  • Ensure performance across a range of activities and metrics within their area.
  • Monitors processing throughout shift to assure safety, quality, and delivery. 
  • Tracks procedural verifications, including process records. 
  • Tracks KPIs and updates SQDC boards.

 

CUSTOMER RELATIONSHIPS

  • Participates in and supports Customer quality audits. 

 

SKILLS & QUALIFICATIONS

 

  1. Bachelor’s degree or equivalent combination of education/experience in a technology and/or engineering field preferred
  2. Experience in contract sterilization (EO, Steam), chemical processing and processing equipment is desired. 
  3. Five (5) years' experience in a production environment with two (2) years of supervisory experience preferred.
  4. Must be able to read, write, and speak fluent English.
  5. Intermediate Microsoft Office skills
  6. Must be willing to carry a phone and be available 24/7 in the event of an emergency.
  7. Must be willing to work established shifts (as well as overtime as needed)
  8. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, fractions and decimals
  9. Must have forklift driving experience
  10. Must be able to read, write, and speak fluent English
  11. Experience with mechanical devices, tools, and testing equipment required.
  12. Utilize technology (laptop and computer software (Microsoft Office)) to perform administrative duties as required.
  13. High level of professionalism accompanied with excellent interpersonal and customer service skills.
  14. Must have excellent time management skills, being able to prioritize multiple priorities at one time.
  15. Ability to work in a fast-paced environment with the flexibility to adjust to and meet changing priorities.
  16. Make good business judgments and decisions in relation to efficiency and effectiveness while meeting daily service expectations.
  17. Must have the ability to evaluate situations, good problem-solving skills, and prioritize factors in decision making.
  18. Must be dependable and punctual.
  19. Maintains a positive attitude and a strong work ethic.
  20. Must be authorized to work in the United States

 

ESSENTIAL FUNCTIONS/PHYSICAL REQUIREMENTS

 

  1. Must be able to regularly lift and move up to 25lbs.
  2. Frequently lift and move up to 50lbs.
  3. Occasionally lift and move up to 100lbs.
  4. Push/pull weights of 100lbs +
  5. Must be able to tolerate exposure to high/cold temperatures and high humidity
  6. Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk and hear.
  7. Must be able to crouch, stoop, or squat to work inside or under equipment, or move through low headroom spaces.
  8. Able to occasionally work in tight spaces.
  9. Must climb ladders and/or scaffolds and work above floor height.
  10. Requires routine pushing, pulling, grasping, and manual dexterity in the use of hands, arms and shoulders.
  11. Occasionally exposed to wet or humid conditions, fumes and airborne particles, and outdoor weather conditions.
  12. Distance vision/peripheral vision, depth perception, and ability to adjust focus.
  13. Must be able to sit and drive for long periods of time during travel.
  14. Must be able to occasionally walk great lengths at a time and stand for extended periods of time.
  15. Must be able to perform work from floor level to above shoulder height if needed.
  16. Must be able to operate a computer and other office machinery such as a calculator, copy machine and printer.

 

 

EOE/AA/M/F/Veteran/Disability


Benefits

  • Medical Insurance
  • Dental Insurance
  • Life Insurance
  • Short Term Disability Insurance
  • Paid Vacation
  • 401(k) Retirement Plan with company match
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