Quality Assurance Specialist 1

2 weeks ago

Mississauga, Canada The Cooper Companies Full time

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.
- 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.
- 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.

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