Scope:

The Life Science Quality Assurance Coordinator is an entry level position to support the Quality Assurance Team. The role will help with administrative tasks within the electronic Document Management System (eDMS) and overall Quality Management System (QMS). The individual will have the opportunity to collaborate within the Quality team and greater operations team to help with minor nonconformities, troubleshooting, reconciliation, and investigations.

Job Summary:

The Life Science Quality Assurance Specialist I is an entry level quality professional that is responsible for quality oversight of processes in Quality Management Systems, operations, review and/or release of products. This role is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs, and work instructions. In this role the candidate will work with cross functional teams and acquire in depth knowledge of Quality Assurance (QA) and the importance of quality processes in patient care. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity and possess a strong continuous improvement mindset.

Responsibilities

Essential Functions & Accountabilities:

Support Quality Systems under the direction of Quality Assurance Manager
Follows 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.
Perform other Quality Assurance Duties as required.

Travel:

☐ Not applicable to Quality Specialist I

Qualifications

Scope:

Job Summary:

Essential Functions & Accountabilities:

Support Quality Systems under the direction of Quality Assurance Manager
Follows 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.
Perform other Quality Assurance Duties as required.

Travel:

☐ Not applicable to Quality Specialist I

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