Purpose of Job: To manage the Quality Control functions and the Laboratory of the site. Laboratory equipment is maintained to ensure operability and availability and manage quality technicians' tasks/activities.
Essential Function 1: Site Quality Control
Develop new QC methods and optimize existing methods to ensure accurate analytical results Number of non-conformances Implement required analytical methods from the Development & Application department and USP Test standard Responsible for all incoming, in-process, and outgoing quality control, and validation data Number customer QNS, supplier QNS, and Non-conforming Reports Represent the QC department during audits Responsible to refuse and stop production as warranted Responsible for archiving batch files and retaining samples Provide technical support to production Translate customer specifications into internal specifications (In Process Control) Number of customer complaints, QNS Essential Function: Responsible for calibration and maintenance of QC appliances Instrument downtime and availability Ensure that required calibration of laboratory instrumentation is carried out according to schedules Number of deviations from schedule Essential Function 3: Management Systems Authorize and release COAs for all products that leave the site - SAP certificate profiles Number of Customer Complaints Create and maintain all QC documents in GMS Ensure compliance with required legal and ISO standards Ensure that environmental monitoring is carried out as required in conjunction with safety & environmental Internal audit findings Support the following systems: Customer Complaints, Supplier Complaints, and Customer Audits RH, Temp., and Dusting monitoring reports Essential Function 4: Environmental Safety Health Affairs
Investigate all incidents in the quality department and assist with site incident investigation Number of safety deviations Ensure compliance of quality staff to site, business unit, and company safety and health standards Essential Function 5: People and Administration
Manage quality staff to ensure efficient and timely service to internal and external customers. Number of complaints Is responsible for people development in the QC department. Replace the Quality Manager when the QM is absent. Ensure that qualified technicians are adequately trained to function in the organization. Training and development matrix available and updated. Required Education and Business Experience: Education: A bachelor's degree in quality or science is required. Associate degree and five years of experience in a manufacturing environment accepted in lieu of BA degree Business experience: Five years of supervisory experience in a quality department is required, preferably in manufacturing. Experience with ISO 9001, 14001, OSHAS 18001, ISO 15378, or cGMP is a plus Metrology knowledge, and experience an advantage.
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