Quality Assurance Specialist I

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

 

• 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. 

Travel: 

☐  Hybrid (1-3 days a week onsite)

☐  Remote

• 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.

Computer Skills: 

• Knowledge of Master Control, or similar eQMS a plus 

• Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.

Adaptability 

• Responds effectively to changing constraints. 

• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.

• Understands the drivers of change and anticipates the implications of changing political and practical circumstances 

• Applies a preventative instead of corrective approach

• Attention to Detail 

• Checks information, picks up inconsistencies and mistakes and can make detailed comparisons between similar sources 

  • Positive work attitude that supports teamwork and continuous improvement.

Decision Making 

• Makes pragmatic decisions based on range of factors 

  • Able to make decisions quickly where necessary, based on incomplete information 

  • Demonstrates logic to back up decisions 

  • Excellent critical analytical skills – ability to find root cause of why and issue occurred. 

Initiative 

• Identifies ways to improve processes/situations 

  • Takes responsibility for improvements or solving problems. 

    • Must display eagerness to learn and continuously improve.

    • Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal Skills 

    • Socially capable - interacts confidently, reads the situation 

    • Empathetic and can evaluate likely reactions 

    • Collaborative approach  

Results Oriented 

• Ability to focus on important issues only. Risk based approach  

  • Regularly refocuses on results 

  • Demonstrates a drive to exceed performance targets 

Task Management 

• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion

  • Prioritizes and monitors tasks progress

  • Makes realistic estimates of time and resource requirements 

 

Work Environment:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

• While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision. 

 

Experience/ Education:

• 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.

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.  If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com