Quality Assurance Specialist

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

Current Openings for Quality Assurance Specialist Jobs at Jost Chemical Co.