Quality Management Systems (QMS) Specialist - Knipper HEALTH

Overview

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The QMS Specialist is responsible for administrating Knipper's Corrective and Preventive Action, Quality Events, Deviations, and Change Management processes to ensure that Knipper's quality system operates according to current Good Manufacturing Practices. The QMS Specialist will be an administrator or power user of the electronic quality management system (e-QMS) and Document Control. The QMS Specialist is responsible for reviewing and approving investigations, CAPA Plans,  Effectiveness Checks and Change Requests to ensure investigations and actions are commensurate with the risk of the issue or change. The QMS Specialist will support all business units through training and support of the eQMS License Holders and controlled document owners.   This will include entry of records, monitoring workflow, editing and providing feedback, and reviewing and approving records for closure.

100% on-site role based out of Lakewood, NJ or Charlestown, IN location.

Responsibilities

• Write and revise Quality System procedures and work instructions to meet regulatory and client requirements.
• Support internal and regulatory audits and inspections.
• Conduct Internal and external Quality Systems audits as assigned.
• Review and approve planned and unplanned deviations and change requests.
• Train eQMS License Holders on the use of the system.
• Train and provide guidance to contributors on conducting and writing investigations, the requirements and output of the various stages of CAPA and the use of Root Cause Analysis tools such as 5Why, fault tree analysis and Ishikawa diagrams.
• Review and approve quality investigations, CAPA, effectiveness checks, and change control in support of all business units and maintain all applicable quality records in a consistent, compliant, and timely manner.
• Coordinate with contributors across business units and departments, such as Client Services, Compliance, and Operations, to drive the timely and effective resolution of incidents and Quality Events using business communications, trending, root cause analysis, risk management, and corrective/preventive action activities to allow the business to improve product and process quality.
• Manage the initiation, revision, and retirement of controlled documents for all business units, including Standard Operating Procedures, Work Instructions and Quality Agreements in accordance with current Good Manufacturing and Good Distribution Practices.
• Train Document Champions to document control and change management processes and requirements.
• Assign appropriate roles and permissions to eQMS license holders.
• Monitor the effective use of the eQMS to identify and implement improvements such as workflow configuration or training.
• Analyze data to determine the need for additional investigations and stand-alone CAPAs.
• Issue monthly, quarterly, and annual reports to present information to top management.
• Influence without authority and work across organizational boundaries.
• Exhibit strong collaboration and team-building skills.
• Execute document controls and management of changes.

The above duties are meant to be representative of the position and not all-inclusive.

Qualifications

MINIMUM JOB REQUIREMENTS:

• Bachelor’s Degree
• 3 – 5 years of Quality Systems experience in a regulated environment. Experience in Medical Devices, Biologics, or Pharma is preferred.
• Relevant ASQ or RAPS certifications are preferred but not required.
• Ability to analyze data and present data.
• Ability to work independently and in a team environment
• Excellent communication skills (verbal and written) and customer service.
• Ability to prioritize multiple tasks and accomplish them in a timely manner.

KNOWLEDGE, SKILLS & ABILITIES:

• Proficient in Microsoft Office applications. WORD Level – basic skills required; EXCEL – Intermediate Level required.
•   Experience utilizing eQMS, ERP, and data center programs like/TrackWise Digital, SharePoint, and Microsoft Dynamics.
• Strong knowledge of CAPA system requirements and Root Cause Analysis tools
• Ability to maintain the highest level of confidentiality.
• Strong understanding of Quality System requirements of ISO 9001:2015 or ISO 13485:2016, current Good Manufacturing Practices, 21 CFR Part 820, 21 CFR Part 210 & 211, 21 CFR Part 11, and  ICH Q9 required.

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or business community members.
• Ability to effectively present information to top management, public groups, and members of senior management.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write technical reports, business correspondence, and procedure manuals.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an equal opportunity employer.