Director of Quality

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

Responsibilities and Duties

Position Summary:

The Director of Quality works with the Executive teamto set the strategic and scalable direction for Quality Assurance and QualityControl. This role provides dailyoversight of Quality, continually monitor and report the progress to themanagement team and owners toward the quality goals. Responsible for compliancewith the requirements of 21CFR Parts 110/111 and 210/211. This position is responsible for thecompany’s compliance with policies and procedures which ensures Praxis meets orexceeds regulatory and customer expectations. This position works with allsupervision and employees to ensure that cGMPs and Praxis SOPs, policies andwork instructions are being followed.

Essential Functions and Responsibilities:

• Maintain state of control of the companies Quality deliverables, final responsibility for providing effective quality controls for the organization.
• Establish and ensure compliance (staff & systems) with written procedures to ensure that packaged products conform to the customer's specifications and regulatory requirements.
• Responsible for the Quality department employees to guide and assist in their work and professional development.
• Assure the proper handling of customer complaints and approve customer complaint deviations.
• Continually work 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.
• Ensure effective leadership development, workforce planning, employee relations and engagement, safety/risk control, and work rule education and employee discipline.
• Ensure all Quality and Safety procedures and processes are always followed.
• Facilitates and Lead in handling of customer complaints, audits, and any inspection.
• Ensure compliance with written procedures for sampling, inspecting, and testing of packaging materials, in-process and finished products.
• Approves all customer Quality Assurance Agreements (QAAs) and ensures SOPs are updated as required in the agreements.
• Furnish internal reports that are useful to the daily operations of the organization.
• Establish guidelines for response to deviation investigations / CAPA plans and provide guidance as needed.
• Ensure policies, procedures and work instructions within the document control process are up to date and executed in a timely fashion.
• Responsible that the Quality Department uses provided resources (time, money, space etc) efficiently and effectively.

Knowledge & Experience:

• Bachelor Degree, required.
• 5-7 years Quality experience required.
• 3-5 years’ experience with FDA audits, compliance regulations and GMP, required.
• Experience developing systems and workflows in a customer oriented business that supports a growing company, required.
• Experience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories, required.
• Quality System Management (QSM) system design and evaluation, required.

Computer/CommunicationSkills:

• 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.
• Ability to present training topics to small or medium sized groups.
• Basic comprehension of the English language: reading and writing skills to understand and complete necessary 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.