Job description
Full-service CDMO in the biologics space seeks an experienced Quality Assurance Supply Chain Auditor to join the team!
This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $125,000 per year
A bit about us:
-
Our client is a biopharmaceutical CDMO that services manufacturing projects at all stages: process technical transfer, scale-up, cGMP manufacturing of bulk drug substance, through commercialization.
Why join us?
-
Company-paid medical insurance
Dental, Vision Insurance
Generous PTO
Growing organization
Generous Bonus Plan
Job Details
-
RESPONSIBILITIES:
REQUIREMENTS:
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. #scientific #cdmo #netsuite #quality #master-control #consumables #audit #supplier #approved-supplier #approved-materials #manufacturing #equipment #materials #indtier1
This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $125,000 per year
A bit about us:
-
Our client is a biopharmaceutical CDMO that services manufacturing projects at all stages: process technical transfer, scale-up, cGMP manufacturing of bulk drug substance, through commercialization.
Why join us?
-
Company-paid medical insurance
Dental, Vision Insurance
Generous PTO
Growing organization
Generous Bonus Plan
Job Details
-
RESPONSIBILITIES:
- At the beginning of each calendar year prepare a schedule and coordinate Supplier audits and share with Manufacturing teams.
- Coordinate Supplier audits and material approvals with materials management.
- Use a risk assessment process to determine the impact of a supplier on product quality and consequently if a supplier audit is required, and if required, the audit should be an onsite audit or a desk audit.
- Prior to each onsite audit, prepare a scope for the audit and use a risk assessment process to determine the focus of the audit.
- Prepare an audit report immediately after each onsite audit, listing observations and based on the observations disposition the Supplier as approved (subject to addressing certain observations) or, conditionally approved (subject to addressing certain observations), or not approved.
- Prepare an audit report after each desk audit, listing observations and based on the observations disposition the Supplier as approved (subject to addressing certain observations) or, conditionally approved (subject to addressing certain observations), or not approved.
- Maintain the AVL and the AML in accordance with Supplier qualification activities.
- Prepare Supplier Quality Agreements and submit to the AVP of Quality and Regulatory for approval.
REQUIREMENTS:
- Associates degree, Bachelor’s degree or appropriate experience
- Minimum 5 years of Supplier Audit experience.
- Must be willing to travel and work on the weekends, as needed.
- Preferably have experience within Master Control and NetSuite
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. #scientific #cdmo #netsuite #quality #master-control #consumables #audit #supplier #approved-supplier #approved-materials #manufacturing #equipment #materials #indtier1
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