Quality Assurance Coordinator

CooperCompanies • Sugar Land, TX

4d

About The Position

The Life Science Quality Assurance Coordinator is an entry-level position designed to support the Quality Assurance Team. This role involves assisting with administrative tasks within the electronic Document Management System (eDMS) and the overall Quality Management System (QMS). The individual will have the opportunity to collaborate with the Quality team and the broader operations team on minor nonconformities, troubleshooting, reconciliation, and investigations. The Life Science Quality Assurance Specialist I is an entry-level quality professional responsible for quality oversight of processes within Quality Management Systems, operations, and the review and/or release of products. This role ensures overall quality in assigned areas by executing site policies, procedures, programs, and work instructions. The candidate will work with cross-functional teams, gaining in-depth knowledge of Quality Assurance (QA) and the significance of quality processes in patient care. Strong written and verbal communication skills are essential for fostering cross-functional collaboration and partnerships, leading by positive influence, maintaining high integrity, and possessing a strong continuous improvement mindset.

Requirements

• Entry level position
• Support Quality Assurance Team
• Assist with administrative tasks within the electronic Document Management System (eDMS) and overall Quality Management System (QMS)
• Collaborate within the Quality team and greater operations team
• Assist with minor nonconformities, troubleshooting, reconciliation, and investigations
• Responsible for quality oversight of processes in Quality Management Systems, operations, review and/or release of products
• Ensure overall quality in assigned areas through the execution of site policies and procedures, programs, and work instructions
• Work with cross functional teams
• Acquire in depth knowledge of Quality Assurance (QA) and the importance of quality processes in patient care
• Strong written and verbal communication skills
• Foster cross-functional collaboration and partnerships
• Lead by positive influence
• Maintain a high level of integrity
• Possess a strong continuous improvement mindset
• Follow written instructions in the routine review of laboratory records in accordance with site standard operating procedures, good documentation practices (GDP) and Quality Management Systems (QMS)
• Maintain understanding of company standards, guidelines and QMS processes to support and help stakeholders with applicable instructions
• Perform control processes such as data entry counting, verification, issuance, receipt, and reconciliation of any discrepancies
• Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness
• Maintenance of Record Management, electronic Document Management System and update document binders, indexes, and documentation therein
• Communicate and collaborates with appropriate staff and Project Teams regarding Document revision staff
• Aid in writing, revising procedures and formatting
• Perform compliance review on executed records for completeness of all required testing and documents for various processes
• Supports Minor Non-conformance investigations which may contain basic root cause analysis
• Uses existing procedures to solve routine or standard problems
• Basic conceptual knowledge and practices associated with Document Review
• Recognizes errors in records and resolves them in a timely manner
• Supports basic improvement projects
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records

Responsibilities

• Support Quality Systems under the direction of the Quality Assurance Manager.
• Follow written instructions in the routine review of laboratory records in accordance with site standard operating procedures, good documentation practices (GDP), and Quality Management Systems (QMS).
• Maintain an understanding of company standards, guidelines, and QMS processes to support and assist stakeholders with applicable instructions.
• Perform control processes such as data entry, counting, verification, issuance, receipt, and reconciliation of any discrepancies.
• Perform data entry, data analysis, tracking, trending, and create graphs and reports as required for each Quality Management System module, monitoring timeliness and effectiveness.
• Maintain Record Management and the electronic Document Management System, updating document binders, indexes, and related documentation.
• Communicate and collaborate with appropriate staff and Project Teams regarding Document revision staff.
• Assist in writing, revising, and formatting procedures.
• Perform compliance reviews on executed records for completeness of all required testing and documents for various processes.
• Support Minor Non-conformance investigations, which may include basic root cause analysis.
• Use existing procedures to solve routine or standard problems.
• Possess basic conceptual knowledge and practices associated with Document Review.
• Recognize and resolve errors in records in a timely manner.
• Support basic improvement projects.
• Work cooperatively in a team environment to maintain cross-functional and cross-site processes and procedural consistency for quality systems records.
• Perform other Quality Assurance duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed