Job Description

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 manner
• Manages customer submitted deviations & CNQI
• Manages customer and consumer complaints/problems, elevating to Leadership when needed.
• Manages Quality Control lab (Chemistry, Stability, Packaging) and issues that are associated with its function
• Ensures that Quality Control lab is always audit ready
• Manages the Retain room and is associated activities to ensure customer requirements are met.
• Manages all associated non conformances and CAPA activities for Quality Control Lab
• Supervises 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 necessary
• Serves as an investigator on quality issues
• Ensures CAPA plan commitments are appropriate
• Works with QA management to support all pre-audit preparations, internal and external audit training
• Creates customer performance reports for customer and leadership reviews
• Responsible for personal and teams adherence to all company policies and procedures
• 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
• Ensures proper PPE’s and Safety procedures are followed
• Instills a sense of quality through modeled quality behaviors and mindset
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed

Performs any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.

Qualifications

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