QA SPECIALIST

Job Summary:

The Quality Assurance (QA) Specialist is mainly responsible for executing administration of Quality Releases and Quality Certification of Adhesives Research product sold from the Glen Rock site; administration of Document Control, Training System and DMF Submission System; participating in validation/qualification activities as required and maintaining various files and databases, performing and participating in internal and external audit activities and managing and/or supporting other projects as assigned.

Essential Functions:

• Responsible for final release of product prior to shipment to customers.

• Reviews internal batch records generated in Polymerization, Mixing, Siliconization, Coating, Slitting, Converting and Packing operations for compliance to internal and external requirements
• Generates and reviews quality certification documents that are sent to the customers with product
• Monitors products nonconformances, to ensure appropriate disposition occurs prior to shipment
• Monitors Consent to Ship (CTS) and Fitness for Use (FFU) documents for product release
• Updates and maintains customer quality certification templates as well as Q notes in Oracle as required
• Responsible for filing and maintaining related documents as required

• Responsible for administering the company’s controlled documents system in accordance with internal procedures that include customer, external regulatory agencies and company requirements.

• Performs document management responsibilities, facilitates activities, and develops expertise within the system
• Reviews all documents in the workflow for format, appropriateness of the templates, relations to other documents and document integrity
• Enforces AR Document Control requirements in order to meet internal and external needs
• Participates in internal and external audits, and regulatory inspections by providing documentation support and assures the compliance and inspection/audit readiness of the Document Control System
• Leads/Assists continuous improvement efforts that focus on improving the compliance and business efficiency of the Document Control System
• Generates, reviews and reports metrics as required
• Trains/assists associates on the proper use of the Document Control System (Universal Content Management or UCM)
• Assists in upgrades/validation activities related to the Document Control System

• Responsible for administering the company’s training system in relation to release of controlled documents in accordance with applicable internal procedures

• Coordinates setting up of training notifications for controlled documents prior to their release for initial entries or revisions, and assures adequate completion of required training
• Assists maintenance of training databases with current courses, syllabi, and personnel information when responsible associate in Human Resource Department is not available.
• Maintains data accuracy in training database as applicable
• Assists in upgrade/validation activities related to the systems as required

• Performs internal audits as assigned and participates in others as required, and supports external audits

• Responsible for administration of Drug Master Files, and electronic submission system

Skills:

• Proficient in the use of current quality management system with respect to generating NCRs, ascertaining product status, managing inventory movement, etc.

• Able to read technical documents and reports and identify errors and potential noncompliance issues based on process knowledge and understanding of protocols is required. Examples of technical documents include but are not limited to:

• Standard and non-standard batch records for different products
• Test Sheets for incoming and final products and associated test results
• Validation Protocols for qualification of manufacturing processes and/or electronic systems
• Process Monitoring Reports related to product releases for systems including On-Line coating thickness gauging, coater, slitter, converter vision inspection systems for product defects, temperature charts etc.
• Reports generated in current electronic quality management system
• Drug Master Files (DMF), and related electronic system documents/requirements

• Able to interpret situations and make difficult decisions under pressure (example: pressure to release product as truck is waiting at the dock, or expediting document approvals and training through the document control system)

• Able to perform and review calculations, graphical analysis and statistical analysis

• Able to act as a liaison between manufacturing, customer service, planning, quality control and process engineering in resolving batch record and manufacturing issues

• Able to utilize written, email and verbal communications with key functional areas to drive improvements and resolve deficiencies identified

• Understands currently published Drug Master File requirements and follows up with future publications of FDA for maintenance of current DMF files and new submissions. Be able to operate/maintain the system used for DMF submissions.

• Familiar with all requirements including ISO, customers’ and internal, and supports to increase the department’s compliance to these standards

• Proficient in Microsoft Office and others such as UCM, CAP, Cunesoft,Trackwise etc. to maintain spreadsheet/databases for batch record review and product releases, quality certification, QC test data, document control, training, and administration of DMF Files

• Understand current validation process and validation protocol requirements

• Able to utilize proactive planning, prioritizing and coordination of daily activities required

• Keen attention to detail is required for all tasks

• Elevates significant/critical issues to management

• Performs other duties and responsibilities as assigned

Job Specifications:

• Requires an Associate’s or Bachelor’s in Biology/Chemistry or technical discipline plus a minimum of one year relevant experience or five years related experience/accomplishment
• Working understanding of Good Documentation Practices related to record review and batch release
• Excellent interpersonal and communication skills
• Conforms to Frontline Leadership Basic Principles, Company Policies, Quality Systems, etc.
• Ensures safe work practices and behaviors when in hazardous areas