Quality Assurance Specialist - Supplier Quality

Celgard•Fremont, CA

60d•$95,000 - $110,000•Onsite

About The Position

This role is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier’s compliance and managing the BNS supplier qualification program. The role also supports Bionova Scientific’s self-inspection program, as well as management of the client audits and health authority inspections. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment.

Requirements

Bachelor of Science degree or equivalent in a scientific field
Minimum of 5 years’ GMP Quality Assurance and Quality Systems experience.
Experience with ERP systems and eQMS systems is a must
Expertise in data analysis, trend analysis.
Strong understanding of pharmaceutical manufacturing processes and documentation requirement
Excellent written and verbal communication skills to effectively document findings and present technical information
Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)
Effective organization and planning skills.
Demonstrated ability to deal with frequent changes, delays, or unexpected events
Effective interpersonal and communication skills. Communication at all management levels and all staff is required
Proficiency with relevant quality management systems and software

Responsibilities

Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards
Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc.
Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements.
Perform actions associated with Change Control documents, discrepancy management and supplier investigations
Conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented procedures
Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality
Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement
Enforce quality assurance policies and procedures to maintain product quality and compliance.
Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken
Compile metrics for presentation to senior management and communicate disposition status in a timely manner
Coordinate the inspection readiness program for Bionova Scientific
Preparing for and supporting regulatory agency audits, client audits and self-inspection