Nesher Pharmaceuticals (USA) LLC
  • 07-Oct-2019 to 06-Dec-2019 (CST)
  • Quality Assurance
  • St. Louis, MO, USA
  • Salary
  • Full Time

Summary

Perform assessments, audits, and other related tasks that fall under the broad category of Quality functions.  Such tasks will include evaluating investigations, CAPAs, Change Controls, Validation Plans, etc., associated with the Quality oversight of Quality Control Laboratories and R&D Operations.  Responsible for the data integrity of Certificates of Analysis and R&D batch documentation, including review of laboratory data, Master Batch Records and Master Packaging Records, Validation Protocols and Qualifications.  Ensure adherence to CD related commitments by preparing and collating the specific records required to support Quarterly Audits.  

Essential Duties and Responsibilities

  • Review and approve NOEs, CAPAs and Change Controls resulting from Laboratory and AR&D activities.
  • Conduct activities associated with the investigation process to meet the needs of the Company and to comply with all necessary regulations.  Such activities may include conducting investigations or evaluating investigations conducted by other departments or other Quality functions.
  • Approve validation protocols prior to implementation for QC and AR&D equipment/facilities/processes.
  • Write, review and revise SOPs to reflect current processes.
  • Perform QA review of laboratory data, SOPs, Protocols, Methods, and Specifications.
  • Responsible for maintaining database for Certificates of Analysis and Cleaning Validation Data.
  • Responsible for maintaining database and hard copy file of Development Methods, Specifications, and Protocols and Reports.
  • Perform periodic walk-through audits of the laboratory.
  • Assist in cGMP audits of R&D manufacturing, testing, or clinical facilities (internal or external).
  • Perform QA review of Utility and Facility Activities for the Laboratory. 
  • Review Master Batch Records and Master Packaging Records for completeness and for inclusion of all QA tasks and requirements, as applicable.  Such records may be associated with product development or production. 
  • Support product transfer activities, as needed.
  • Assist in complying with the commitments made as part of the Consent Decree and other compliance programs.
  • Provide support during third party audits.
  • Participate in FDA audits and other regulatory inspections, as needed.
  • Provide team leadership, as required, as well as team member support.
  • 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

  • Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices, FDA, DEA and other legislation regulating the production operation.
  • PC proficiency using Microsoft Office required; Trackwise®, Visio and Project a plus.
  • Outstanding oral and written communication skills.
  • Strong interpersonal skills to effectively resolve conflicts and bring individuals together to work as teams.
  • Ability to think critically and apply critical thinking processes to investigations, CAPAs, auditing, and data reviews.
  • Proven organizational and time management skills with ability to effectively manage multiple priorities in a fast paced, dynamic environment.
  • Proven experience and demonstrated problem solving and project management skills. 
  • Self-driven to work independently on complex problems. 

EDUCATION/EXPERIENCE

  • Bachelor's degree in the sciences preferred; or equivalent combination of Bachelor's degree and pertinent experience in pharmaceutical or other highly regulated industry.
  • A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements. 
  • Three years' experience in Quality role that involves use of laboratory equipment and analytical instrumentation to perform data reviews, oversight of floor activities and/or other QA-related functions, in a pharmaceutical or other highly regulated environment, such as medical devices.

 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 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 is an equal opportunity employer M/F/D/V.

Nesher Pharmaceuticals (USA) LLC
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