Praxis Packaging
Quality Manager - Customer Care and Quality Control Lab
Praxis Packaging, Grand Rapids, Michigan, us, 49528
Overview:
Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. This position works closely with the Quality Operations Team, Quality Systems Team and other internal department Managers and Supervisors at Praxis to assure compliance with regulatory and customer requirements. This position involves program leadership for the timely and effective management of all customer-directed issues, responses, investigations, and CAPA plans. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.Responsibilities:Manages customer communicates in written, verbal and proactive mannerManages customer submitted deviations & CNQIManages customer and consumer complaints/problems, elevating to Leadership when needed.Manages Quality Control lab (Chemistry, Stability, Packaging) and issues that are associated with its functionEnsures that Quality Control lab is always audit readyManages the Retain room and is associated activities to ensure customer requirements are met.Manages all associated non conformances and CAPA activities for Quality Control LabSupervises a diverse workforce of Quality Employees.Assists Human Resources with interviewing and managing performance.Ensures employees are trained according to their roles.Addresses complaints and problems, elevates to Leadership when needed.Contains and places product/components on HOLD, as necessaryServes as an investigator on quality issuesEnsures CAPA plan commitments are appropriateWorks with QA management to support all pre-audit preparations, internal and external audit trainingCreates customer performance reports for customer and leadership reviewsResponsible for personal and teams adherence to all company policies and proceduresWorks to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actionsEnsures proper PPEs and Safety procedures are followedInstills a sense of quality through modeled quality behaviors and mindsetFlexibly works other shifts, shifts maybe 8, 10 or 12 hours as neededPerforms any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.Qualifications:Bachelor Degree, required or equivalent combination3-5 years Quality experience requiredExperience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories preferred.
Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. This position works closely with the Quality Operations Team, Quality Systems Team and other internal department Managers and Supervisors at Praxis to assure compliance with regulatory and customer requirements. This position involves program leadership for the timely and effective management of all customer-directed issues, responses, investigations, and CAPA plans. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.Responsibilities:Manages customer communicates in written, verbal and proactive mannerManages customer submitted deviations & CNQIManages customer and consumer complaints/problems, elevating to Leadership when needed.Manages Quality Control lab (Chemistry, Stability, Packaging) and issues that are associated with its functionEnsures that Quality Control lab is always audit readyManages the Retain room and is associated activities to ensure customer requirements are met.Manages all associated non conformances and CAPA activities for Quality Control LabSupervises a diverse workforce of Quality Employees.Assists Human Resources with interviewing and managing performance.Ensures employees are trained according to their roles.Addresses complaints and problems, elevates to Leadership when needed.Contains and places product/components on HOLD, as necessaryServes as an investigator on quality issuesEnsures CAPA plan commitments are appropriateWorks with QA management to support all pre-audit preparations, internal and external audit trainingCreates customer performance reports for customer and leadership reviewsResponsible for personal and teams adherence to all company policies and proceduresWorks to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actionsEnsures proper PPEs and Safety procedures are followedInstills a sense of quality through modeled quality behaviors and mindsetFlexibly works other shifts, shifts maybe 8, 10 or 12 hours as neededPerforms any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.Qualifications:Bachelor Degree, required or equivalent combination3-5 years Quality experience requiredExperience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories preferred.