Description
Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan is committed to Quality, Integrity ad Service in all that we do.
The Supplier Quality Specialist is a member of the Quality Systems department responsible for overseeing and assisting in all aspects of Supplier Quality control and assurance.
Essential Duties and Responsibilities:
* Serve as process owner for the Supplier Management and Monitoring process
* Review and approve incoming inspection, material specifications, and material qualification results to monitor supplier performance and issue NCMR's as needed
* Perform supplier audits and visits as needed in order to verify their CAPAs, assess their performance, and overall QMS effectiveness
* Onboard and vet new suppliers as necessary and maintain an Approved Supplier's List
* Review and approve all supplier CAPAs and change requests and communicate to the organization as needed
* Actively monitor and track supplier performance and report the metrics to management for review
* Other duties as defined by Bryllan
Behavioral Expectations:
* Strong work ethic and ability to accomplish tasks without supervision,
* Exhibits leadership, both by work and example,
* Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment,
* Excellent interpersonal skills with the ability to communicate effectively,
* Basic computer skills (proficient in Microsoft Office applications),
* Excellent communication skills, both written and verbal,
* Possess honesty and integrity with a commitment to the highest legal and ethical standards,
* Treats every person with courtesy and respect,
* Knowledge of CGMP and regulatory principles,
* Commitment to quality in the manufacturing process,
* Ability to independently analyze and resolve complex issues,
* Strong sense of initiative, accountability, and responsibility
Work Experience and Education Requirements:
* BS in scientific discipline
* Biotech / pharmaceutical industry experienced preferred
* 5+ years experience in Supplier Quality preferred
* Demonstrated knowledge and understanding of CGMP and CGMP Quality Systems
* Certified Lead Auditor preferred
