Jost Chemical Co.
  • 29-Aug-2018 to 31-Dec-2018 (CST)
  • Operations
  • St. Louis, MO, USA
  • 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.


Background

¨      Works under general direction of the Quality Assurance Manager in a c-GMP regulated manufacturing environment operating under Q7A standards. A certain degree of creativity and latitude is expected.

 

 

Tasks

¨      Review and authority to approve production batch records

¨      Assist in interpreting new and existing FDA and other US regulations, agency guidelines and internal policies to assure compliance in company products and procedures, testing or recordkeeping

¨      Conduct internal and external quality audits and determine adequacy of subsequent preventative actions

¨      Prepare reports, analyses and make recommendations for resolution of material non-conformance incidents; participate in material review of non-standard production

¨      Review QA specifications, test methods, sampling plans and related written procedures to ensure compliance with compendia and meeting customer needs

¨      Conduct complaint investigations and provide response to customer; develop and track subsequent corrective actions; provide responses to customer other QA inquiries

¨      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

¨      Review and advise on labeling to ensure compliance with regulations

¨      Establish, review and approve stability protocols

¨      Develop and conduct training programs regarding company quality systems

¨      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 Europe

¨      Customer Interaction

¨      Importance of written communication

¨      Maintain and enhance site safety

 

 

Specifications

¨      B.S. in Chemistry, Biology, Biochemistry, or any other Scientific discipline or training

¨      At least (3) years of quality assurance experience in a manufacturing environment

¨      Knowledge of:

  • c-GMP regulations (Broad level)
  • REACH
  • FDA and other US regulations (Broad level)
  • HACCP
  • European Regulations
  • Basic mathematics
  • MS Office software package (Broad level)

¨      Skill in:

  • Chemistry
  • Developing creative solutions to non-standard quality and compliance problems
  • Data processing with attention to detail and documentation
  • Working effectively and efficiently on multiple projects at once
  • Working effectively in a team environment
  • Responding to rapidly changing demands

¨      Ability to:

  • 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
  • Problem solving
  • Logical reasoning

 

 

FLSA

¨      Exempt

Jost Chemical Co.
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