Nesher Pharmaceuticals (USA) LLC
  • 11-Jul-2017 to 09-Sep-2017 (CST)
  • Quality
  • Bridgeton, MO, USA
  • Full Time

Competitive Benefits Package


Summary

Assure drug products are processed in accordance with Current Good Manufacturing Practices (cGMPs), master batch records, and have the safety, identity, quality, and purity they purport to possess prior to release.  Assist production staff with production problem resolutions and documentation.  Provide training on cGMPs/SOPs for Quality Assurance and production personnel as assigned. 

Essential Duties and Responsibilities

  • Perform direct oversight of manufacturing activities to ensure cGMP compliance.
  • Verify manufacturing area cleanliness, environmental status, and room documentation prior to authorizing use of the facility/area.
  • Perform bend, AQL, and laboratory sampling as required.
  • Perform physical in-process testing as required per facility.
  • Perform Real-Time Batch Record Reviews on the floor during operations.
  • Submit laboratory samples in accordance with procedures.
  • Perform equipment start-up and line clearance verifications.
  • Perform post processing batch record reviews/correction assistance.
  • Perform post processing yield verifications.
  • Compile and review batch disposition packets.
  • Conduct routine and scheduled inspections of plant areas, equipment and personnel to ensure cGMP compliance. If discrepancies in cGMPs, procedures, systems or techniques are observed, initiate appropriate corrective action, document the issue/event, and if necessary, immediately stop production until the issue is corrected.
  • Participate in and lead, as appropriate, problem analysis and problem-solving activities to address quality issues.
  • Monitor work in process for proper use of materials, correct recordings and possible sources of cross-contamination and report all deviations to the shift QA Supervisor.
  • Assist with validation sampling as needed/required.
  • Perform daily QA lab scale verifications as applicable.
  • Routinely check calibration dates for current date and informs QA Supervisor of any discrepancies.
  • Inspect and approve use of designated equipment after product change-over.
  • Responsible for stopping production when quality discrepancies are discovered.
  • Perform sampling of critical utilities.
  • Responsible to review batch documentation, including the completed Certificate of Analysis, and release raw materials, in-process product, and/or finished product to the next stage of processing or, in the case of finished product, to distribution. 
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.
  • Knowledge and understanding of the importance of clean processing/equipment work areas.
  • Extensive knowledge of cGMPs and the ability to apply them in the manufacturing/packaging process.
  • Skilled in generating and preparing written reports.
  • Outstanding oral communication and conflict resolution skills.
  • Ability to use:  scale balance, LOD instrument, micrometer, friabulator, hardness testers, calculator, disintegration apparatus, viscometer and computer.
  • Demonstrated ability to read and comprehend written technical procedures as well as revise SOPs as needed.
  • Demonstrated ability to comprehend, interpret, enforce and apply written Current Good Manufacturing Practices and Standard Operating Procedures.
  • Demonstrated ability to accurately perform math calculations required by work assignments.
  • Ability to provide cGMP/SOP training for QA and production personnel.
  • Ability to independently perform day-to-day operations with minimal supervision including manage individual workload and timelines; identify and work independently on resolution of complex issues and corrective actions; effectively share information and communicate to peers and management; independently prepare reports, and complete assigned projects.

KNOWLEDGE/SKILLS/ABILITIES 

  • Knowledge and understanding of the importance of clean processing/equipment work areas.
  • Extensive knowledge of cGMPs and the ability to apply them in the manufacturing/packaging process.
  • Skilled in generating and preparing written reports.
  • Outstanding oral communication and conflict resolution skills.
  • Ability to use:  scale balance, LOD instrument, micrometer, friabulator, hardness testers, calculator, disintegration apparatus, viscometer and computer.
  • Demonstrated ability to read and comprehend written technical procedures as well as revise SOPs as needed.
  • Demonstrated ability to comprehend, interpret, enforce and apply written Current Good Manufacturing Practices and Standard Operating Procedures.
  • Demonstrated ability to accurately perform math calculations required by work assignments.
  • Ability to provide cGMP/SOP training for QA and production personnel.
  • Ability to independently perform day-to-day operations with minimal supervision including manage individual workload and timelines; identify and work independently on resolution of complex issues and corrective actions; effectively share information and communicate to peers and management; independently prepare reports, and complete assigned projects.

EDUCATION/EXPERIENCE

  • Associate's degree in related discipline or Certification as a Quality Auditor (CQA), or the equivalent in education and experience in a direct QA or inspection role with increasing levels of responsibility.
  • Three years' experience in a Quality Assurance role in pharmaceutical or other highly regulated industry.
  • Experience in inspection of raw materials, in process and finished pharmaceutical product sampling. 

Work environment

 The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
  1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects. 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
  1. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
  2. Atmospheric conditions sometimes expose individual to dust, for which protective      equipment is available.
  3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
Nesher Pharmaceuticals (USA) LLC
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