Nesher Pharmaceuticals (USA) LLC
  • 13-Sep-2017 to 12-Nov-2017 (CST)
  • Quality Control
  • Bridgeton, MO, USA
  • Full Time

Competitive Benefits Package


summary

Manage the Quality Control function, to include incoming samples to Laboratory for finished goods, raw materials, components, validations, water and EM samples. Ensure accurate and expedient results in compliance with all Regulatory and Company specifications. Ensure testing meets all applicable cGMP and that testing, procedures, and specifications meet regulatory requirements.

essential Duties and Responsibilities

  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
  • Oversee the daily operations of the QC laboratory to maintain a high degree of performance, compliance, efficiency and output of reliable/accurate data.
  • 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.
  • Manage the review and approval of specifications and test methods for finished goods and raw material methods in an accurate, timely manner.
  • Direct the creation, review and approval of QC related documents (specifications, methods, SOPs, protocols, etc.).
  • Lead the investigational process to ensure thorough investigation into failing results.
  • Assist in GMP audits whether internal or external to ensure compliance is maintained.
  • Plan and manage execution of approved recommendations from audits and investigations.
  • Ensure the completion of all non-conformances, deviations, and other quality related issues associated with laboratory investigations.
  • Review and approve investigation reports in a timely manner to ensure they meet cGMP, GLP requirements and are compliant with all regulatory requirements.
  • Determine lab capacity and resources needed to maintain QC turnaround time for finished goods and raw materials.
  • Review and ensure timely revisions and implementation of compendial changes for all monograph products and raw materials.
  • Ensure the transfer of finished goods and raw material test methods occurs in a timely manner from R&D or any other sources.
  • Ensure timely updates of all stability profiles to support all NDAs, ANDAs and DMFs.
  • Review and update SOPs and direct timely revisions of these documents as required.
  • Participate in GMP audits of laboratories on an as-needed basis to ensure compliance is maintained.
  • Evaluate equipment needs for the laboratory as necessary, including automated systems that may be required to maintain performance levels for reproducible and reliable test results.
  • Perform other related duties as assigned to meet departmental and Company objectives.
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KNOWLEDGE/SKILLS/ABILITIES

  • Solid working knowledge in analytical chemistry test methods with a working knowledge of validation concepts for lab methods.
  • Strong knowledge of cGMPs EU, FDA, and other appropriate pharmaceutical regulations.
  • Understanding of microbiological techniques.

 

    • Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
  • Effective communication skills to communicate in a clear, concise manner whether in oral, written or presentation form.
  • PC proficiency using Microsoft Office.
  • Good attention to detail and follow-through.
  • Ability to critically review analytical data for troubleshooting.

 

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EDUCATION/EXPERIENCE

    • Bachelor's degree in chemistry or a science related field; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Minimum five years' supervisor/management experience in the pharmaceutical or related industry with good knowledge of production processes as well as laboratory methods.

 

 

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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