Senior Supplier Quality Systems Engineer
Company: Beacon Hill Staffing Group
Location: Maryland Heights
Posted on: August 6, 2022
- Manage the Supplier Quality Program in compliance with
applicable regulations by working with suppliers to maintain a
- Conduct supplier audits, evaluations, and assessments
- Issue supplier complaints and drive for resolution and
- Develop and maintain Supplier Quality Agreements
- Perform Quality review and approval of Change Controls.
- Perform statistical evaluations to identify trends and report
on Supplier Quality metrics
- Conduct internal quality audits and develop and assess
subsequent corrective action recommendations.
- Provide support for FDA or other regulatory inspections and
- Provide leadership and coordination on assigned projects.
- Ensure a safe and quality working environment through training,
awareness and compliance to regulatory guidelines and
- Bachelor of Science degree in Life Sciences or Engineering
- Minimum of 5+ years of Quality experience in a finished
pharmaceutical manufacturing environment with a strong
understanding of and exposure to applicable quality systems.
- Minimum of 2+ years of experience in Supplier Quality
Management and supplier auditing.
- Minimum of 2+ years of experience in supporting on-site
- Must have working knowledge in Supplier Quality Management,
Supplier Auditing, Supplier Assessment, Supplier Quality
Agreements, and Corrective Action.
- Must have a working knowledge of cGMP guidelines and their
application in a controlled aseptic environment.
- Must have strong technical knowledge in pharmaceutical quality
systems with proficiency in the following: Stability, Change
Control, Internal Auditing, Corrective Action Program, Exceptions,
Out of Specification Investigations, Customer Complaints,
Regulatory Affairs, Document Management, and Annual Product
- Must be thoroughly familiar with applicable regulatory
guidelines concerning the establishment, validation, and
documentation, equipment, processes, and facility systems.
- Must have a working knowledge of Change Management.
- Must have experience with statistical tools.
- Proficient in the use of Microsoft suite of products.
Keywords: Beacon Hill Staffing Group, Springfield , Senior Supplier Quality Systems Engineer, Other , Maryland Heights, Illinois
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