Johnson Matthey Quality Specialist I in Devens, Massachusetts
Quality Specialist I
Location US - Devens, MA
Requisition Number 13709
Apply Now (https://phh.tbe.taleo.net/phh01/ats/careers/v2/applyRequisition?org=JOHNSONMATTHEY&cws=45&rid=13709)
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. Interacts with personnel from all departments of Johnson Matthey to ensure and maintain a high level of strict GMP compliance.
Reviews batch records, documents, validation protocols, and reports for compliance to internal and GMP standards.
Reviews QC analytical data from in-process, release and stability testing.
Maintains and monitors an assigned coordinator role which includes the review of trended data to identify areas for improvement.
Supports the department during client audits and FDA inspections, if needed.
Provides Quality Assurance on-the-floor oversight to production and quality control.
Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements.
Carries out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Assists in the scheduling and maintenance of Quality Assurance activities and systems.
Are you the ideal candidate?
BS in a scientific discipline or equivalent with a minimum of 0-3 years’ experience in an GMP regulated industry.
Associates degree in a scientific discipline or equivalent work experience with a minimum of 2-5 years of experience in a pharmaceutical, medical, or quality field.
High School Diploma or equivalent with a minimum of 5+ years of experience in a pharmaceutical, medical, or quality field.
Knowledge of Quality Assurance oversight and support for all phases of clinical trials.
Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
Knowledge of and previous experience with GMP, ICH Q7, and 21 CFR Part 11 preferred.
Familiar within FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals preferred.
Experience with Microsoft Office and other complex computer software preferred.
Experience with commercial phase pharmaceuticals preferred.
Johnson Matthey is an Equal Opportunity Employer. Johnson Matthey does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, citizenship, veteran status, or other characteristic protected by law.
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