QA Quality Operations Manager

QA Quality Operations Manager

Unette Corp. continues to grow!!! We are seeking an experienced Quality Operations Manager to join our Team at our Production Facility in Randolph, NJ. This is a critical role to our success! The Quality Manager serves as the backup for the Director of Quality in all matters related to Quality and Compliance. The position involves leadership in the development, execution, and operation of the Quality Management System (QMS) and the personnel assigned to operate those systems. This position works with all supervision and employees to ensure that cGMPs and Unette SOPs, policies and work instructions are being followed.

·        Salaried role offering competitive annual pay.

·        Benefits include medical, dental, vision, 401k, paid Vac/Holidays

·        Growing company with excellent opportunity for advancement!

 Essential Functions and Responsibilities:

• Continually work to improve the effectiveness of the quality management system (QMS).
• Oversees key parts of the QMS, including but not limited to: nonconformance reports, customer complaints, corrective and preventive actions and deviations.
• Participates in the Internal Audit program to ensure Quality Management System effectiveness.
• Directs and supervises the QA team (supervisors, incoming inspectors and in-process inspectors).
• Ensures that production floor line clearance and line audits are being conducted as required.
• Assures all shifts are covered when approving and taking vacations, holidays, etc. and provide adequate coverage to fulfill Company’s needs.
• Oversees the QA review of Facility, Equipment and Logistics documentation to ensure compliance.
• Leads the project plans to execute new product launches and line trials, liaison between Production, Quality, and Sales.
• Develops and implements procedures, job processes, qualifications and validations of new product launches to meet customer expectations.
• Manages the monitoring, measurement, and review of internal processes, especially those that affect the quality of product.
• Assists with internal and external investigations, including use of fishbone diagram or 5-whys, to identify root cause.
• Manages the temperature and humidity monitoring of the facility.
• Directs additional AQL inspections and drafts rework instructions as needed.
• Tracks and trends key quality performance metrics to identify opportunities for improvement.
• Participates in customer quality meetings, conference calls and audits as needed.

 Education, Skills & Experience Required:

• Bachelor in Science (or Arts) degree required.
• Quality Management experience in a manufacturing/production environment.
• Strong knowledge and understanding of 21 CFR 210 and 211 as it pertains to liquid filling and packaging of drug products highly preferred.
• Familiarity with contract and third-party manufacturing experience very beneficial.
• 1-2 years’ experience in Customer/ISO/FDA audits.
• 1-2 years’ experience with validation activities (IQ/OQ/PQ); experience with cleaning validation a plus.
• 3 years of supervision experience
• Proficiency with MS Office programs: Word, Excel, and Outlook, required
• Working knowledge of Enterprise Resource Planning (ERP) related software, preferred

About Unette Corp.:
Unette Corp. is located in Randolph, NJ and is part of Praxis Packaging.  Praxis Packaging is headquartered in Grand Rapids, MI with facilities in New Jersey and Ohio. 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.

We are an independently operated subsidiary of the Huizenga Group. The Huizenga Group is a privately held firm that provides management services to a diverse group of companies. The current portfolio of companies provides products and services for the world adding automotive, pharmaceutical, military goods, medical device, consumer goods and office furniture manufacturers.

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.