Location: Whippany, NJ, USA Department: Manufacturing / Operations
At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world. Overview
POSITION SUMMARY The role of the Supervisor has all the same core Essential and Position requirements as that of the Supervisor. In the Senior Supervisor role, the holder of this position will be expected to lead and mentor the Supervisors within the Dosage Forms unit operations, as well as provide experience, leadership and guidance to the entire organization. He or she will step in to the role of the Manufacturing Manager as needed. This position is not based on length of service. The position of Senior Supervisor is an appointed role based on the demonstrated qualifications and performance of the Senior Supervisor.
This is a cross functional position encompassing, but not limited to the Supervision of the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Tablet Printing, Capsule Sealing, Pilot Plant and Liquid manufacturing processes. ESSENTIAL FUNCTIONS 1. Reports to manufacturing upper management. 2. Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures. 3. Comprehends and adheres to all cGMP's and other Regulatory requirements. 4. Respond to questions from outside regulatory agencies including the FDA, DEA. 5. Comprehends and adheres to all related SOP's as well as Batch Records and Protocols. 6. Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure. 7. Completes all required Training activities. 8. Clearly and accurately completes all required GMP documentation. 9. Perform Room and Equipment inspections and completes all pertinent documentation. 10. Manual Dexterity is required. 11. Other duties as assigned
POSITION QUALIFICATIONS 1. Has authority for personnel actions and oversees most day to day operations of various unit operations within the Dosage Forms area. 2. Ensures all department personnel adhere to all Health and Safety Regulations, Policies and Procedures and performs safety audits as scheduled. 3. Perform work in compliance with established cGMP and SOPs. 4. Respond to questions from outside regulatory agencies including the FDA, DEA. 5. May be responsible for the receipt, storage and issuance of all Controlled Substance material activities within the Dosage Forms area. 6. Generates Demand Work Orders as needed. 7. Establishes or revises SOP's as required. 8. Initiates Planned and Unplanned Deviations as required. 9. Schedules and assigns manufacturing personnel to their daily job assignments. 10. Evaluates for disposition employee Paid Time Off requests. 11. Secures quotes and arranges for vendor service calls as needed. 12. Orders supplies for the department as needed. 13. Generates employee Performance Appraisals and Disciplinary documentation. 14. Computes amounts of materials and supplies required for operations, based on production schedules, and requisitions or directs the requisition of materials from storage areas. 15. Plans flow of materials through the department and plans work according to manufacturing schedule. 16. Interfaces with others in the organization as well as clients to ensure customer deadlines are met. 17. Inspects and approves manufacturing rooms and equipment for cleanliness and completes the required documentation. 18. Manages and schedules employee overtime as needed. 19. Directs workers in adjusting machines and equipment to meet required specifications. 20. Performs batch record reviews prior to disposition. 21. Develops, recommends, and implements measures to improve production methods, equipment performance, and quality of product. 22. Analyzes and resolves work problems or assists workers in solving work problems. 23. Ability to move/push up to 50lbs. 24. Must be able to move about the facility 25. Must be able to remain in an upright position for periods of time 26. Must be able to remain sedentary for periods of time
EDUCATION: 1. Bachelor's degree from four-year College or university; or three to five years related experience and/or training; or equivalent combination of education and experience. 2. Ability to read, analyze, and interpret SOPs, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, etc... Ability to effectively present information and respond to questions from groups of managers, clients and outside regulatory agencies. 3. Computer literacy and solid communication skills (in English) are a must. 4. Must demonstrate Basic Math skills.
EXPERIENCE: 1. Five to seven years related experience and/or training; or equivalent combination of education and experience. 2. Experienced interaction with regulatory agencies including the FDA, DEA. 3. Solid understanding of cGMP practices and concepts. 4. Mechanically inclined candidates are preferred.PI154930429