What are the responsibilities and job description for the Quality Assurance Specialist I position at CooperSurgical?
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 familie
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 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.
- 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, 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.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
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.
- 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 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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