Quality Operations Manager

Praxis Packaging Solutions, a leader in the secondary packaging industry, is searching for a Quality Operations Manager.

Position Summary:

The Quality Operations Manager works closely with the Quality Managers and the Production Department to ensure Quality Assurance compliance with regulatory and customer requirements. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.

Essential Functions and Responsibilities:

• Ensures the content and executional effectiveness of the QA Programs.
• Responsible to ensure products meet quality and efficiency standards set by the company. 
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and
  preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification
  procedures; monitoring inventories.
• Validates quality processes by establishing product specifications and quality attributes; measuring
  production; documenting evidence; determining operational and performance qualification; writing and
  updating quality assurance procedures.
• Maintains and improves product quality by completing product, company, system, compliance, and
  surveillance audits; investigating customer complaints
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and
  trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Direct and supervise Quality Assurance Team
• Collaborates with the Engineering Administrator and Director of Quality, to ensure compliant
  validation/qualification of all appropriate equipment and/or processes.
• Works 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 actions
• Supervises a diverse workforce, @ 5-10 Quality Employees
• Instills a sense of quality through modeled quality behaviors and mindset

Knowledge Experience:

• Bachelor’s degree, required or equivalent combination
• 3-5 years Quality experience required
• Supervision experience required
• Experience in managing various levels of employees with different educational backgrounds, work style
  habits, and employment histories.

Computer/Communication Skills:

• Working knowledge of MS Office programs: Word, Excel, and Outlook, preferred
• Working knowledge of Enterprise Resource Planning (ERP) related software, preferred
• Working knowledge of QMS Software Systems (TrackWise, ETQ, Intellex etc..), preferred
• Ability to present training topics to small or medium sized groups
• Ability to speak, read and write English in a manner that is sufficient for effective communication with
  supervisors, employees, and customers: to include reading and writing skills to understand and complete
  necessary customer paperwork, required

About Praxis Packaging:

Established in 1989 and headquartered in Grand Rapids, MI, Praxis Packaging Solutions is a full service contract packaging company specializing in Secondary Packaging operations for the consumer product, cosmetics, food & beverage, over the counter (OTC) and prescription (Rx) pharmaceuticals, and promotional products industry as well as Primary Filling and Packaging of Oral Solid Dosage Tablets.

Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.