Supplier Quality Specialist
3 weeks ago
Supplier Quality Specialist, | Just-Evotec Biologics, Inc. Redmond WA
Just is seeking a highly motivated Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated scientist to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Supplier Quality group to provide Supplier Quality and Raw Material Quality in support of the GMP operations, GMP document authoring/ revision and disposition of raw materials. As a member of the SQ team, the successful candidate will have GMP Quality experience assessing suppliers compliance and/or raw material quality. ASQ auditing certification or comparable is a plus. The ideal candidate has a high attention to detail, is organized in their work, has strong written and verbal communication skills, and works well independently and in teams.
This role is remote with some travelling to Redmond and Seattle, WA site
Responsibilities:
Conduct supplier quality system audits and follow up activities
Coordinate audits through a Third Party Auditor service
Raw material disposition
Creation/revision of raw material specifications
QA oversite of Warehouse and Raw Material Quality Operations
Manage current regulatory requirements, internal, environment related to incoming materials
Escalate supplier or raw material quality issues to stakeholders through appropriated escalation processes
Perform Root Cause Analysis of non-conformances and lead implementation of corrective & preventive actions
Manage Supplier Notifications, Recalls
Coordinate Supplier Quality Agreements and Non-disclosure agreements with Legal
Perform actions associated with Change Control documents, Nonconformances, and supplier deviations, including ownership of these records
Providing updates to Supplier Records
Completing Supplier data for metrics and risk management documents
Managing low risk (low criticality) supplier accounts, as needed
Supporting Supplier Quality projects, as needed
Requirements:
BSc in Biochemistry, Chemistry or related field and 5 8 years of experience in QC/QA
Minimum of 2+ years working directly with suppliers
Knowledge of cGMP regulatory requirements ICH, FDA, EMA
Experience in the pharmaceutical, or medical device industry
Communicate effectively both verbally and written with supplier and internal personnel in a professional manner
Preferred qualifications:
Working knowledge and experience with ERP enterprise software such as SAP is preferred
4+ years of RM Quality or Supplier Quality experience
Experience in FDA/partner inspections is desirable preferred
Certified to a nationally recognized quality certificate (e.g., ASQ) is desired
Working knowledge of compendia (USP/NF, Ph.Eur., JP, etc.)
The base pay range for this position at commencement of employment is expected to be
$80,300 to $125,350.
Base salary offered may vary depending on individuals skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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