Quality Lead Auditor

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 30 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.

Company:

Bionique Testing Laboratories LLC

Job Description:

Summary:

The Quality Lead Auditor will be responsible for overseeing and managing all aspects of quality assurance and compliance within the organization. This role involves ensuring that all quality agreements, both supplier and client, are adhered to, conducting internal and client audits, managing supplier relationships and audits, and handling regulatory inspections and client regulatory requests. The Quality Lead Auditor will also be responsible for managing client notifications, addressing customer complaints, and responding to supplier questionnaire requests. This role requires a high level of expertise, independent judgment, and decision-making.

Key Accountabilities and Responsibilities:

• Develop, implement, and maintain quality agreements with suppliers and clients.
• Conduct internal quality audits to ensure compliance with company standards and regulatory requirements.
• Lead client audits and ensure all client requirements are met.
• Manage supplier relationships and conduct supplier audits to ensure compliance with quality standards.
• Oversee regulatory inspections and ensure the organization is prepared for any regulatory audits.
• Handle client regulatory requests and ensure timely and accurate responses.
• Manage client notifications and ensure all client communications are handled professionally and promptly.
• Address customer complaints and ensure they are resolved in a timely and satisfactory manner.
• Respond to supplier questionnaire requests and ensure all information provided is accurate and complete.
• Contribute to department strategy to determine objectives to meet strategic goals

• Additional related duties as assigned

Additional Accountabilities and Responsibilities

• Works independently and proactively
• Proactively communicates and furthers understanding of quality principles amongst colleagues and supervisors
• Effective problem solving and conflict resolution skills in a cross functional setting
• Fluent in regulatory and industry standards

Requirements:

• Bachelor's degree or equivalent required; experience can be substituted for education
• Minimum of 3 years of experience in quality assurance or a related field.
• Certified Auditor preferred
• Strong knowledge of quality management systems and regulatory requirements.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team, maintaining effective working relationships with colleagues, vendors, and clients
• Attention to detail and strong organizational skills.
• Ability to handle multiple tasks and projects under deadline pressure and independently
• Strong organizational and time management skills
• Knowledge of occupational safety and health rules and regulations
• Knowledge of CFR 210 and 211 required
• Excellent IT skills including but not limited to Microsoft Office Suite, electronic scheduling tools, and equipment software applications
• Candidates must be willing and able to travel domestically and/or internationally as needed

Physical Requirements:

• Prolonged periods of sitting on a chair, working at a desk and working on a computer and/or telephone
• Must be able to lift up to 20 pounds

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.

Salary : $60,000 - $75,000