Location: Rochester,NY, USA
We are looking for a Quality Manager to join our Kodak team in the Life Sciences group in Rochester, NY to support a new manufacturing facility. The near-term focus is on establishing and managing our quality systems in our new facility. Longer term focus will be to provide ongoing quality and management support to the ramp and on-going manufacturing in the factory. An ideal candidate will be a high-performing Quality Manager who can establish and meet/exceed organizational objectives in quality and standards compliance. This is a hands-on Quality Manager role, implementing and managing quality systems for a growing manufacturing organization.
Specific Duties and Responsibilities:
Primary Contact point for regulatory agencies with respect to maintenance of 3rd Party audited certifications and licenses.
Host inspections and audits of facility from regulatory agencies and customers.
Foster an ethic of quality in all aspects of the company s related business activities.
Responsible for all aspects of the company s GMP QMS. This includes but is not limited to:
Ensure appropriate validation and qualification of facilities, equipment, GMP systems, and testing procedures are performed as required and reviewed and approved prior to implementation and during the item life-cycle.
Review and approve all final test results (releases) and intermediate results, when applicable.
Ensure the GMP facilities and equipment are maintained and calibrated according to requirements. Ensure that OOT, out of calibrations, malfunctions, and excursions are adequately investigated and resolved.
Ensure that initial and continuing training of GMP staff is performed and adapted according to need.
Complaints Handling and Management.
Ensure deviations, CAPAs, incidents, and OOS/OOT are adequately investigated and resolved.
Manage GMP Service and Technical Agreements as required.
Maintain GMP Approved Suppliers List and assess and quality new GMP suppliers when applicable.
Review and approve all GMP documents, forms, and templates prior to implementation. Additionally, write, revise, and review SOPs, controlled forms and related documents as needed to ensure best practices and current operations.
Maintain and ensure the continued suitability of the GMP operations monitoring systems and those operations that may impact GMP operations.
Ensure that all GMP staff perform their agreed tasks and testing of samples in keeping the QMS current and reviewed at appropriate intervals.
Oversee and manage QC Laboratory operations as necessary.
Oversee and execute, appropriate, internal audits of the GMP operations and those operations supporting GMP operations that include, but limited to sample receipt, booking in, training, test method execution, reports and related LIMS activities (electronic or manual).
Additional Responsibilities:
Ensure that all test procedures, utilized standards, and specifications are up to date with the current respective domestic and international requirements and regulations.
Serve as the company s QMS Management Representative and a member of the management group or team.
Provide quality and technical leadership and guidance as necessary.
Provide duties and responsibilities as assigned by supervision.
Ensure working relationships with clients.
Lead in development of the process for the coordination and resolution of supplier quality issues. Includes investigation, resolution, follow-up and corrective actions.
Initiate and/or maintain the facility FDA or ROW health agency registration and product listing as applicable including UDI maintenance.
Qualifications:
(Education, Experiences and Skills):
Bachelor s degree required. Graduate degree preferred but not required.
10+ years related work experience preferred:
Experience in a FDA regulated environment: Medical Devices and/or Pharmaceuticals required. Knowledge of GMP required.
Experience in training, investigations, root cause analysis, Corrective Action Preventive Action (CAPA), auditing (internal and suppliers), leading process improvement, OOS, customer complaints, leading regulatory audits (FDA and ROW), and product quality reviews, developing QMS, related SOPs and protocols. Overseeing a QC Laboratory and samplers, reviewing inspection and testing results, process validations. Knowledge and Performance of various QC Laboratory testing.
Other roles and responsibilities may apply.
Certifications Preferred:
cGMP, GLP or ISO Auditor, ASQ or similar
Accountability:
Senior/ Management (or at least for the Management Representative role).