CooperSurgical is looking for a Life Science Quality Assurance Specialist II to maintain and ensure compliance to the Quality System programs, including supplier quality, investigation systems, quality event reporting, training, and document review. The role will collaborate with cross-functional teams to identify root causes and implement risk remediation.
Requirements
- 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.
- Knowledge of Master Control, or similar eQMS a plus
- Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
- Candidates must show knowledge and proficiency in the Quality Assurance Specialist I role
- Candidate should demonstrate knowledge of regulations and standards such as: AABB, AATB, FACT, FDA (HCT/P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO regulations
- Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
Responsibilities
- Provide Quality oversight and support as needed by Quality customers.
- Support and partake in Quality Management System Processes such as: Document Control Program: review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.
- Change Management Program: Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control.
- Deviations and Nonconformances: Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events
- Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.
- Validations: Review and approval of equipment, systems validation/ qualification, and any design transfer to operations
- Quality Metrics: Perform trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations.
Other
- The individual will have the opportunity to learn and mentor Quality team members.
- The Specialist will collaborate and help Quality Assurance customers identify root cause and risk remediation.
- 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.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with three to five years related experience and/or training. OR four to six years related experience and/or training; or equivalent combination of education and experience.
