Nesher Pharmaceuticals (USA) LLC
  • 25-May-2018 to 24-Jul-2018 (CST)
  • Quality Assurance
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Provide Quality Assurance supervisory oversight of assigned QA functions and areas of manufacturing to ensure drug products are processed in accordance with cGMPs. Responsible to assess, investigate and effectively resolve processing issues in conjunction with subject matter experts, and in accordance with standard operating procedures.

 

essential Duties and Responsibilities

    • Provide comprehensive formal and informal leadership to promote a positive work environment and communicates overall business expectations to the plant working groups.
    • Supervise coordinators and their activities, ensuring they meet all training requirements.
    • 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, work with Operations management to perform root cause analysis, assist in the initiation and investigation of deviations and the development of CAPAs to correct issues.
    • Responsible to stop production when quality discrepancies are discovered. Initiate NCRs and work with Operations management to ensure the NCR root cause is determined, CAPA initiated and affectivity check is done post-NCR to ensure CAPA's effectiveness.
  • Responsible for pre-release batch record reviews and resolution of any potential product issues prior to batch release to packaging and distribution. In short, ensure all cGMP and company requirements are met prior to formal product release.
  • Actively work on the floor to provide oversight to QA and Operations personnel to ensure compliance with standard operating procedures, housekeeping and all other aspects of pharmaceutical manufacturing.
  • Perform testing of in-process samples, take samples, inspect and approve use of designated equipment after product changeover and perform other related activities as necessary.
  • Work with validation personnel (processing and cleaning) to ensure protocols are followed, appropriately sampled, and samples delivered to the Quality Control lab.
  • Proactively identify opportunities for improvement to product, process, and systems relating to production or QA activities.
  • Ensure compliance with DEA requirements for the site.
    • Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
  • Actively participate in regulatory inspections as directed by management; perform such duties as accompanying Government officials during agency inspections and providing requested information in a timely and professional manner.
  • Responsible for SOP reviews and revisions of procedures impacting QA, or related activities.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.
  •  

KNOWLEDGE/SKILLS/ABILITIES

  • Knowledge of pharmaceutical cGMPs and ability to apply that knowledge to manufacturing operations and QA.
  • Demonstrated working knowledge of statistics and their application to the Quality Assurance function.
  • Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices, DEA, and other legislation regulating the production operation.
  • Understanding of and ability to conduct root cause analyses and identify CAPA actions to prevent recurrences.
  • Proven leadership qualities to mentor, coach, train and develop others.
  • PC proficiency using Microsoft Office Suite, computerized inventory and laboratory systems, etc.
  • Detail oriented with strong communication and conflict resolution skills.
  • Ability to provide cGMP/SOP training for QA and production personnel.

 

EDUCATION/EXPERIENCE

  • Bachelor's degree, preferably in Chemistry, Biology or other science discipline; or the equivalent in pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Five years' experience in pharmaceutical or highly regulated industry.
  • Experience in a lead role in Quality Assurance or Operations desired.

 

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, reach, 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 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. Normal office conditions.
  1. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
  2. 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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