Supplier QA Analyst

Purpose:
This role is responsible for Supplier Quality at the BLI site to ensure the quality of purchased materials and managing the supplier audit and maintenance processes. The individual enables and supports supplier QA activities by coordinating supplier introduction maintenance investigations corrective actions audit preparation and execution and change management. The analyst maintains accurate supplier and audit records in OneTrack supports policy and procedure updates and serves as a key liaison between suppliers site teams and the global supplier quality COE to ensure compliance with corporate and regulatory requirements.

Main Responsibilities:

• Coordinates and resolves quality and performance issues with suppliers Manufacturing Quality Assurance and other stakeholders.
• Manages implementation of new and existing processes impacting vendor product quality assurance.
• Establishes and documents contact with suppliers regarding quality issues (e.g. nonconformity deviation defect report).
• Performs assessment and manages review of supplier change notifications for incoming materials. Assigns actions as appropriate to local cross-functional team.
• Manages Approved Supplier List by maintaining supplier records in OneTrack and OneVault including but not limited to quality agreements material content statements specification agreements supply chain documentation change records assessments and certifications.
• Coordinates quality questionnaires with suppliers.
• Maintains internal quality agreements within the AbbVie network.
• Coordinates with material management to maintain SAP or other quality systems with current specifications approvals supplier status and audit records.
• Facilitates and manages the audit preparation process for scheduled periodic supplier audits ensuring user sites and impacted teams are prepared.
• Reviews and processes audit and change requests following up for additional information as needed.
• Provides technical input and support for updates to policies and procedures and change management requests at both the site and global level.
• Supports questions and provides guidance to internal stakeholders regarding supplier audits and processes; escalates issues as required.
• Maintains supplier performance metrics for monthly and quarterly management review.
• Participates in department continuous improvement efforts and cross-functional projects.
• Monitors department budget and escalates issues as needed.

Qualifications :

Qualifications:

• Bachelors degree in Microbiology Biochemistry Engineering or a scientific discipline.
• Minimum 2 years of experience in a supplier controls role in the biopharmaceutical manufacturing industry.
• Technical and professional skills including good verbal and written communication problem solving analytical interpersonal and negotiation skills.
• Strong computer skills in Microsoft applications (Word Excel Access PowerPoint).
• Experience analyzing data and trends drawing sound conclusions to ensure business unit compliance.
• Experience with TrackWise and Veeva Vault preferred.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time