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 supplier's 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 is based in Redmond, WA with some travelling to Seattle, WA site as required.
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, Non-conformances, 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 devices industry with a background in compendia.
• 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 individual's 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.