Senior Quality Assurance Associate

Johnson Matthey Pharma Services brings innovation and a depth of knowledge and experience to the discovery, process development and cGMP manufacturing of new therapeutic molecules. Our dynamic growth continues to create exciting opportunities where chemists collaborate on research and development, process development and production, analytical chemistry and chemical synthesis projects.

 

We are currently searching for a dynamic individual to fill the position of Senior Quality Assurance Associate.  Position Responsibilities include:

 

Reviewing corrective actions and ensuring they are completed.

Reviewing and approving deviations and investigations and providing periodic status reports to management.

Writing audit plans and conducting internal audits.

Review and approval of controlled documents.

Auditing executed records to determine fitness for use of the resulting product.

Provide Quality System advice to team members and coach project teams on production expectations.

Write SOPs and cGMP documents.

Participate in regulatory inspections and client audits.

Coordinate preparation of regulatory submissions

Write, review and approve master qualification and validation protocols.

Review and approve executed qualification and validation protocols wth guidance.

Disposition raw materials, intermediates and final products.

 

Qualifications include, B.S. in a scientific discipline or equivalent with chemistry and/or microbiology coursework, 2-5 years of relevant experience in an FDA regulated industry, QA experience with API production preferred, familiarity with ICH Q7A and ICH Q3C Guidances.

 

Johnson Matthey Pharma Services offers competitive pay and an excellent range of benefits including Heath, Prescription, Dental, Flexible Spending Accounts, 401(k) and more.