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

summary:

Responsible for thorough investigation of quality control laboratory and manufacturing process deviations including: OOS, OOT, and customer complaints. Determination of root cause, initiation of corrective/preventative actions, and correction of the deficiencies identified during investigation process. Responsible to provide proactive corrections based on trends and assessments to prevent reoccurrences that may lead to or result in rejection of product, recall and/or field alert. Work with cross-functional investigation leads, assign investigations, follow up, and ensure all investigations close in a timely manner. This position requires working with minimal supervision to manage investigations from initiation to completion.

 essential Duties and Responsibilities:

  • Responsible for handling process deviations, complaints, out of specification (OOS) and Out of trend (OOT).
  • Responsible for risk assessment reports based on deviations and the impact(s) to the product, process, and patient health and safety.
  • As part of each investigation gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on a previously manufactured product, as well as the risk to future operations.
  • Prepares and analyzes manufacturing and laboratory analytical trend data, and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
  • The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
  • Provide technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
  • Updates and maintains all quality management systems in compliance with various governing procedures and policies as they relate to investigations, CAPAs and performs trend analysis for cause of events.
  • Works independently to comply with procedure driven guidelines relating to deviation and complaint investigations and makes decisions that directly affect patient health and safety.
  • Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to subsequent actions and Investigations in order to maintain compliance in this area
  • Provide immediate supervisor and site leadership team with quality KPI's for deviations and CAPA's. Escalate risk associated with closure of deviations to immediate supervisor.
  • Accountable for the implementation of global quality policy related to deviations.
  • Responsible for training manufacturing personnel on CAPA's and deviations.
  • Ensure events are triaged and initiated on TrackWise within 24 hours.
  • Support Nesher's adherence to cGMP regulations by independently monitoring and performing trend analyses for Nesher processes such as deviation investigation and CAPA effectiveness to communicate results to the applicable departments and to facilitate proactive process improvement.
  • Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES:

    • Strong technical writing skills.
    • Demonstrated knowledge of Quality Assurance, Quality Control, Validation and pharmaceutical process improvement concepts and the ability to apply cGMPs.
    • Detailed working knowledge of Quality Systems, cGMP regulation and compliance.
    • Proven communication skills allowing for the ability to communicate in a clear, concise manner, whether in oral, written or presentation form.
    • Strong interpersonal skills to effectively establish and maintain collaborative cross-functional working relationships with all levels throughout the organization and outside business partners.
    • Strong organizational and coordination skills to effectively manage multiple priorities, projects, duties and tasks concurrently.
  • Demonstrated ability to work independently on complex problems and resolve technical issues.

 

  • PC proficiency in using Microsoft Office, SAP and TrackWise programs.
  • Extensive experience with deviation investigations, CAPA management, effectiveness checks, and training.
  • Experience in preparation, management and follow-up of related FDA inspections.
  • Comprehensive knowledge and experience in the application of FDA regulations and guidelines.

EDUCATION/EXPERIENCE:

  • Bachelor's degree, preferably in Chemistry or Engineering; or the equivalent in pertinent, progressive experience in the pharmaceutical or other highly regulated industry.
  • Five (5) years or more of experience in Quality Control and/or Quality Assurance in the pharmaceutical industry (preferred) or other highly regulated industry  

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, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk and hear.
  2. Constantly use hands and fingers to operate office machines and equipment.
  3. 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.
  4. Exert a negligible amount of force continuously and/or up to five 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. Individual is occasionally in proximity to moving mechanical parts and exposure to chemicals. 

Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

  1. Eye protection (safety glasses), when accessing areas requiring eye protection.
  2. Foot Protection (steel or composite toe safety shoes), when accessing areas requiring foot protection.

Nesher is a proud equal opportunity employer

Nesher Pharmaceuticals (USA) LLC
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