Nesher Pharmaceuticals (USA) LLC
  • 15-May-2019 to 23-Oct-2019 (CST)
  • Quality Control
  • St. Louis, MO, USA
  • Contract

summary

Coordinator is responsible for implementation, modification, maintenance, and oversight of LIMS software in the Quality Control Lab. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.

essential Duties and Responsibilities

  • Review LIMS data and related electronic documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
  • Create and/or review LIMS URS, PQ, and other related validation documentation.
  • Build data platforms and templates to be used in LIMS operations.
  • Identify, troubleshoot, and coordinate corrections regarding LIMS issues or discrepancies.
  • Initiate change controls as necessary to facilitate LIMS functions.
  • Communicate discrepancies to responsible personnel at the site to ensure compliance.
  • Identify areas where LIMS training is needed and provide appropriate training as required to the site personnel.
  • Prepare and maintain LIMS related documents for Quality Control Department.
  • Provide oversight for daily LIMS functions; i.e. scheduling, tracking, labeling, reports, etc.
  • Improve self-awareness and site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.

KNOWLEDGE/SKILLS/ABILITIES

  • Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices (cGMP), FDA, DEA and other legislation regulating the production operation.
  • Proficient in use of LIMS related software.
  • PC proficiency using lab related software, statistical software as well as Microsoft Office.
  • Outstanding oral communication and conflict resolution skills with all levels of the organization.
  • Ability to think critically and apply critical thinking processes to data reliability investigations.
  • Highly organized and able to work comfortably with accelerated work pace.

EDUCATION/EXPERIENCE

  • Bachelor's degree in the sciences or related technical field.
  • Three years' experience in lab and/or IT role involving LIMS applications; i.e. URS, template building, user testing, specifications, and routing LIMS maintenance in a pharmaceutical or other highly regulated environment such as medical devices.
  • A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.

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.
  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. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
  2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
  3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
  4. 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 is an EEO employer

Nesher Pharmaceuticals (USA) LLC
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