Senior QA Associate

Location: Devens, MA
Country: United States
Requisition Number: 9889
Job Family: Quality
Number of Heads Remaining: 1

Description

Johnson Matthey (‘JM’) is a global leader in science that enables a cleaner and healthier world. With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products. Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources. Today more than 14,000 Johnson Matthey professionals collaborate with our network of customers and partners to make a real difference to the world around us.

 

Perform review and release of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing. Assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities.  Determine new methods and procedures for new assignments and provide guidance to lower level Quality Assurance personnel.

 

Key Responsibilities

  • Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards.
  • Maintains and monitors key quality systems such as: deviations, investigations, CAPA; which includes the review of trended data to identify areas for improvement.
  • Conducts system and GMP training.
  • Represent the department during client audits and FDA inspections, if needed.
  • Write and revise Standard Operating Procedures (SOPs) as required.
  • Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
  • Interacts with personnel from all departments of Johnson Matthey to ensure GMP compliance.
  • Recommend the stop of manufacture and/or distribution of product if necessary.
  • Review Master documents such as In-process forms and Batch Records.
  • Approve stability study protocols, validation documents, test methods, and reference standards.
  • Interact with contractor personnel regarding validation and qualification activities.
  • Assist in the scheduling and maintenance of Quality Assurance activities and systems.
  • To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

 

Are you the ideal candidate?

  • BS in a scientific discipline or equivalent with a minimum of 7 years’ experience in an FDA regulated industry.
  • MS in a scientific discipline or equivalent with a minimum of 5 years’ experience in an FDA regulated industry.
  • Experience with Quality Assurance oversight and support for all phases of clinical trials.
  • Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
  • Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
  • Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, Vendor management.
  • Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals. Experience mentoring and training staff members in a Quality department.
  • Experience with Microsoft Office and other complex computer software
  • Experience with commercial phase pharmaceuticals
  • EMEA experience

 

 

 

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