Jost Chemical Co.
  • 21-Mar-2017 to 31-Jul-2017 (CST)
  • Quality Assurance
  • St. Louis, MO, USA
  • Salary
  • Full Time

Medical and dental insurance provided after 60 days of employment. Company-paid life insurance provided after 60 days. Paid time off after 90 days. Nine paid holidays annually.


Off Shift (2nd with some weekends required)

Background

  • Works under general direction of the Quality Assurance Manager in a cGMP regulated manufacturing environment operating under ICH Q7A standards. A certain degree of creativity and latitude is expected.

Tasks

  • Review and production and packaging batch records against SOP and regulatory requirements.  Perform and document product disposition.
  • Track and trend production data and quality metrics to support Annual Product Quality Review reporting.
  • Assist in interpreting new and existing FDA and international regulations, agency guidelines and internal policies to assure compliance in company products and procedures, testing and recordkeeping.
  • Lead cross-functional teams in the investigation and resolution of material non-conformances.  Prepare investigation reports and guide implementation of CAPAs (corrective and preventive actions).Perform subsequent evaluation of CAPAs to determine effectiveness.
  • Review QA specifications, test methods, sampling plans and related written procedures to ensure compliance with compendia and customer needs.
  • Conduct complaint investigations and provide written responses to customers.  Develop and track implementation of corrective and preventive actions.
  • Work with Manufacturing, Sales and Marketing, Research and Development functions to assure FDA and other regulatory compliance requirements are incorporated as part of development process for new products.
  • Coordinate activities of lower level QA staff as needed.
  • Maintain current knowledge of industry practices and regulations related to company products, both in US and internationally.
  • Maintain and enhance site safety.
  • Other duties as assigned.

 Specifications

  • B.S. in Chemistry, Biology, Biochemistry, or any other Scientific discipline
  • At least (3) years of manufacturing or quality assurance experience in a cGMP manufacturing environment
  • Knowledge of:
    • cGMP regulations / ICH Q7A (Broad level)
    • REACH
    • FDA and other US regulations (Broad level)
    • HACCP
    • European Regulations
    • Basic mathematics
    • MS Office software package (Broad level)
    • Operational Excellence methodologies
  • Skill in:
    • Chemistry
    • Technical writing
    • Use of Root cause analysis tools such as 6M and 5 Whys
    • Developing creative solutions to non-standard quality and compliance problems
  • Batch record review and data processing with strong attention to detail
  • Logical reasoning
  • Working effectively and efficiently on multiple projects at once
  • Working effectively in a team environment
  • Responding to rapidly changing demands
  • Ability to:
    • Lead cross-functional teams in problem-solving efforts
    • Perform customer, organizational and regulatory compliance activities
    • Communicate effectively, orally and in writing
    • Review, compile and verify technical data and documents
    • Identify, gather, process and record data accurately
    • Present information in an organized manner
    • Work independently

 FLSA

  • Exempt

 

Jost Chemical Co.
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