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Quality Systems Specialist III

2 months ago

Parsippany, United States Actalent Full time
Seeking 1 Quality Systems Specialist III
Hybrid- Onsite in Parsippany, NJ

Job Description

Job Responsibilities
§Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
§Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
§Independently conducts, completes, and documents major and minor deviation investigations related toGxP operations.
§Conducts, completes, and documents critical deviations with assistance from management and/or more senior level investigators.
§Participates in cross-functional meetings with internal and external parties as required.
§Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
§Supports management and tracking of quality system records (i.e., Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
§Responsible for maintaining tracking tools/databases.
§Responsible for sending periodic reminder notifications to leads/coordinators.
§Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required. Perform additional logistics support for management review process.
Education & Experience
•5+ years of relevant experience in a GMP environment related field and a BS or BA.
•3+ years of relevant experience and a MS.
•Prior experience in pharmaceutical industry is preferred
Knowledge & Skills
•Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
•Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
•Demonstrates knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.
•Demonstrates investigation skills and report writing skills.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.