Quality Assurance Specialist - Supplier Quality
Bionova Scientific LLC Job Description: Position Summary: 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. 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 • 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 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 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 Compensation Range: The base compensation range for this role is between $95,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
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