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Shift Lead Technician

Date: Mar 21, 2019

Location: Coventry, RI, US, 02816

Company: Purdue Pharma L.P. & Affiliates

Job Summary

The chemical manufacturing shift lead technician is responsible for the manufacture of Active Pharmaceutical Ingredients (API) in a safe, compliant and efficient manner. He/she has the experience to consistently perform all required operations at the highest level.  In addition, he/she will assume additional responsibilities on shift such as leading shift change meetings; coordinating process and commissioning/qualification activities; issuing hot work, line break and confined space entry permits; troubleshooting process and equipment problems.  He/she will perform in depth regulatory related activities and assist management in safety, technical and regulatory tasks including training, production planning, report writing and SPC.  Training for and participation on Emergency Response Teams is required.  Availability for overtime and shift work (including rotating shifts and seven-day operation) is also required.

 

Primary Responsibilities

  • Compliance Tasks:

 

  • Work with other chemical technicians to develop safe work practices and improve their technical and record keeping skills.
  • Responsible for safety, health, environmental and regulatory compliance for the shift team.
  • Responsible for the correct execution of all batch records and adherence to all operating procedures.
  • Ensure that all reporting requirements have been fulfilled and provide necessary follow up.
  • Perform the role of DEA coordinator. This requires witnessing all movement of controlled materials.
  • Attend all required cGMP, DEA, and ESHA training.
  • Production Tasks:
  • Oversee Daily Log and Daily Inter-shift Communication Meetings.
  • Write-off materials in SAP to ensure that we maintain near-real time inventory.
  • Oversee all line and confined space entry processes and hot work permits
  • Coordinate and prioritize maintenance activities.
  • Provide training to chemical technicians on production batch records and SOPs.
  • Provide direction to shift teams where necessary to ensure that scheduled operations are executed to plan.
  • Revise and / or develop and implement manufacturing work practice systems in order to improve efficiencies.

Education and Experience

  • High School Diploma or GED. AS/BS degree preferred.
  • 5 + years of related work experience in manufacturing or a chemical or pharmaceutical environment is preferred.

Necessary Knowledge, Skills, and Abilities

The Chemical Manufacturing Shift Lead Technician coordinates all shift production activities ensuring that the plant stays at a high level of regulatory compliance at all times. This will include providing direction to the shift team to ensure that the scheduled operations are executed to plan. Problems will be faced that require timely solutions in order to maintain overall regulatory and / or schedule compliance. These problems may be equipment related, process related or resource related. The position will require the ability to manage multiple projects, tasks and priorities.

Supervisory Responsibilities (if Applicable)

This position requires open communication with all members of the manufacturing, QC, Facilities, Technical Services and QA organizations as well as occasional communication with contractors or visitors.

 

Additional Information

This position is responsible for maintaining safe and efficient manufacturing capabilities in compliance with FDA, DEA, OSHA and other regulatory bodies. Errors in any of these areas can have significant impacts resulting in accidents, environmental incidents and out of specification products, missed shipments, or negative financial impacts. In addition, chemical manufacturing shift lead technician activities require attention to detail in order to maintain schedules and meet department obligations.


Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island

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