Quality Assurance Specialist - Supplier Quality

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.

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
• Cooking for the inspection readiness program for Bionova Scientific
• Preparing for and supporting regulatory agency audits, client audits and self-inspection

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 requirements
• 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

Company Information

Company: 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.

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 Programs

• Healthcare, Dental, and Vision insurance
• Life Insurance and Disability Program: 100% covered by Bionova
• Retail 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