Nesher Pharmaceuticals (USA) LLC
  • 03-Jul-2018 to 01-Sep-2018 (CST)
  • Quality Control
  • St. Louis, MO, USA
  • Full Time

COmpetitive Benefits Package


summary

Supervise QC stability program and lab compliance; to include review, protocols and reports. Maintain Lab SOPs, test methods, protocols, data trending, reports, CoAs, LIMS, and change control.

 

essential Duties and Responsibilities

  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall compliance expectations to team.
  • Oversee stability lab investigations.
  • Ensure the QC Stability and QC Lab operations are concurrent with Regulatory/ FDA requirements and GMPs.
  • Ensure management of working, reference and impurity standard and column management.
  • Ensure contemporaneous documentation.
  • Check raw data, audit trail and software at a given frequency to ensure regulatory guidance compliance.
  • Review and verify electronic data and audit trail before a batch is released or rejected.
  • Review analytical method transfer and method validation documents.
  • Review the OOS/OOT laboratory investigation.
  • Verify the training and qualification of analysts.
  • Participate in investigation of deviations, non-conformances, market complaints, OOS/OOT.
  • Review adequacy of all raw data.
  • Review calibration records of analytical instruments.
  • Ensure retrieval of QC data and support for its presentation during audit.
  • Responsible for implementing company quality ethics policy for data integrity and inform management and on any data integrity issues as per corporate data governance policy.
  • Review and trend lab data such as assay, content uniformity, dissolution, etc.
  • Maintain LIMS (Laboratory Information Management System).
  • Oversee lab compliance, i.e. lab protocols, test methods, specifications, SOPs, reports, and change control.
  • 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.
  • Assist the QC Laboratory as necessary; such as data review, lab investigations, lab instrument documentation, etc.
  • Coordinate QC lab activities, aligned to production demand and serve as Quality Lab Integrator.
  • Manage lab capacity utilization in terms of resources and test equipment.
  • Perform other related duties as assigned to meet departmental and company objectives.
  •  

KNOWLEDGE/SKILLS/ABILITIES

  • Must be knowledgeable about regulatory requirements for GMP stability programs and lab operations, including USP and ICH requirements.
  • Knowledge of the testing procedures used in chemical, physical and micro laboratory testing.
  • Knowledgeable in analytical lab instrumentation; i.e. GC, HPLC, atomic absorption, UV/VIS, IR spectrophotometers, TOC, wet chemistry, and dissolution apparatus.
  • Leadership qualities to mentor, coach, train and develop others.
  • Proven communication skills to communicate in a clear, concise manner whether in oral, written or presentation form.
  • Detail oriented with strong organizational and coordination skills to effectively manage multiple priorities, projects, duties and tasks concurrently.
  • PC proficiency in MS Word, Excel, statistical software (such as MiniTab), and other Windows software.
  • Ability to work with or knowledge of LIMS (Laboratory Information Management System).
  •  

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 or leading team projects preferred.

 

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.
  2. 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.
  3. 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.
  2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
  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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