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Supplier Quality Auditor

Hitachi Chemical Advanced Therapeutics Solutions, LLC

This is a Contract position in Allendale, NJ posted June 17, 2020.

Supplier Quality Auditor

This role ensures and promotes compliance through external auditing of HCATS’ suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on HCATS’ procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.

The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for HCATS and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.

Essential Functions and Responsibilities

  • Develop and maintain a risk-based external auditing program for HCATS harmonized across all sites.
  • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all HCATS facilities to ensure complete profile.
  • Management of ASL to add suppliers and maintain approval status of all suppliers as needed.
  • Based on ASL status, conduct reviews and perform audits to qualify each supplier used.
  • Prepare external audit schedule and conduct audits per the schedule.
  • Prepare and complete audit reports and communicate audit information to cross functional teams within HCATS and supplier within a timely manner.
  • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.
  • Track audit findings for suppliers to completion and ensure timely closure of audit reports.
  • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity.
  • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers.
  • Maintain audit files and ensure all files are properly archived.
  • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed.
  • Ensure that Quality Agreements are generated and enforced at each supplier.
  • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs.
  • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.

Qualifications

  • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.
  • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories.
  • Proven ability to identify, collaborate, and resolve supplier related compliance issues.
  • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,
  • EU and PMDA regulations knowledge and associated guidelines are a plus.
  • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.
  • Certified Auditor or Lead Auditor credentials required.
  • Understanding of the manufacture and testing of cellular and gene therapies is desirable.
  • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.
  • Experience in Quality Assurance, including the ability to identify and resolve compliance issues.
  • Sound knowledge of aseptic processing and supporting technologies.
  • Travel required (approx. 50%)

Competencies/Candidate Profile

  • Must have exceptional written and oral communication skills.
  • Exhibit professional mannerisms when dealing with Clients/Suppliers and HCATS personnel
  • Ability to multi-task is essential.
  • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint.
  • Ability to think strategically and tactically (strong detail-oriented).
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor.
  • Strong analytical and problem-solving skills.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Multi-disciplinary knowledge across GxP functional areas.
  • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities.
  • Good verbal, written communication, and presentation skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence.
  • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors.

Supervisory Responsibility

This position has no supervisory responsibilities.

Minimum Required Training

Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc.

Working Environment

Must have the ability to work in a team-oriented environment and with clients

Must be able to handle the standard/moderate noise of the manufacturing facility

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch.

The employee is frequently required to lift and/or move up to 50 pounds.

This role is sedentary. An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods of time.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.