Sr. QA Specialist, Supplier Quality

This Sr. QA Specialist, Supplier Quality 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 Bionova Scientific's (BNS) supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits, health authority inspections, and quality management review.

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.

Location Fremont, CAHybrid - 3-4 days in office a week

Position 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

Leading and 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 for quality management review 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

Working Conditions:

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently.

Qualifications:

Bachelor of Science degree or equivalent in a scientific field

Minimum of 10 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

The base compensation range for this role is $120,000-$150,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.#LI-MG1#Hybrid