Quality Assurance Specialist I

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 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 crossfunctional collaboration and partnerships lead by positive influence maintain a high level of integrity and possess a strong continuous improvement mindset.

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 documentation review and audit in accordance to Good Documentation Practice (GDP).

Perform data analysis review 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 documentation in accordance to templates and guidelines.

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 Nonconformance 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.

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• Bachelors degree (BA) from fouryear college or university or Associates degree (A.A. with one to three years related experience and/or training.
• OR two to three years related experience and/or training; or equivalent combination of education and experience.
• Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
• Familiarity or experience with the following is strongly preferred: Basic statistics review/approval of documentation; risk tools technical writing and writing/reviewing/approving investigations.
• The candidate should have strong written and verbal communication skills to foster crossfunctional collaboration and partnerships lead by positive influence maintain a high level of integrity and possess a strong continuous improvement mindset.
• Knowledge of Master Control or similar eQMS a plus
• Demonstrated experience and proficiency in Microsoft Office applications Word Excel and PowerPoint.