Quality Assurance Coordinator I

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

The Life Science Quality Assurance Specialist I is 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, contribute to Quality projects and acquire in depth knowledge of Quality Assurance (QA) and the importance of quality processes in patient care. The Quality Assurance Specialist is responsible for the day-to-day operations and partnership of processes within the electronic document control system. 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. 

 

Essential Functions & Accountabilities:

• Contribute to the Quality Systems under the direction of Quality Assurance Manager/ Supervisor
• Responsible for the implementation and adherence to 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 and responsible for adherence to 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.
• Manage 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.
• Lead Minor Non-conformance investigations using root cause analysis.
• Uses existing procedures to solve routine or standard problems.
• Basic conceptual knowledge and practices associated with Document Review
• Recognizes and resolves errors in records and resolves them in a timely manner.
• Contribute to 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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• Bachelor’s degree (BA) from four-year 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 cross-functional collaboration and partnerships, l