Position Summary

The QA Engineer, Document Control Specialist is responsible for supporting the full Quality Management System (ISO 9001 based) at the Philadelphia site under the guidance of the Quality Associate Manager.

Position Duties

• Responsible for executing the Quality function for verifying and maintaining records as directed for non-conformances, deviations, root-cause-investigations, change controls, CAPAs complaints as defined within local procedures.
• Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements
• Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
• Responsible for maintaining Doc. Control KPIs
• Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
• Assist in employee training and maintain employee training records under the QMS.
• Complete data entry in quality databases for new and modified documents.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned. 

Qualifications

Required Education, Training and Experience

• Bachelor's degree required Life Sciences, Engineering, Quality, or related field required
• Education Substitution: In lieu of a Bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted.
• 2+ years of professional related experience with degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
• or 6+ years of professional related experience in lieu of degree in ISO related industry experience required such as quality, manufacturing or other regulated environments

Preferred Education, Training and Experience

• Prior experience executing and building a Quality Management Systems procedures and document control is preferred.
• Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
• Experience managing nonconformances, investigation writing experience and change control preferred
• Demonstrated experience in manufacturing operations is preferred

Knowledge, Skills, and Abilities (KSA’s)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
• Driving continuous improvement by evaluating processes and implementing necessary changes
• Influence change using skills and relationships to persuade others to adopt new ideas, behaviors, or processes.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
• Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
• Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus. 

Supervisory Responsibilities

• Operational or tactical decisions impacting daily team performance with little-to-no supervisory review
• Strategic decisions impacting future direction and alignment with organizational mission with supervisory review/approval required

Supplemental Data

• Includes financial indicators such as site revenue, number and complexity of products, and number of product launches per year
• Includes KPIs such as conformity with quality standards and procedures, document revision turnaround times, and customer complaints
• Includes key internal and external contacts such as Quality leadership, R&D and Operations leaders, QC department, General Managers, Site/Subsidiary Managers, and functional leaders

Working Conditions and Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods
• Ability to ascend/descend stairs, ladders, ramps, and the like

Travel Requirements:

• Domestic travel required: 5%

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