Quality Assurance Specialist II

About CooperSurgical:

CooperSurgical is a leading fertility and womens 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 womens 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 womens health care clinicians. More information can be found at www.coopersurgical.com.

Job Summary:

The Life Science Quality Assurance Specialist II is a mid-level position reporting to the Life Science Quality Manager and/or Supervisor. The role will be the point of contact for inquiry, collaboration, and maintenance of the Quality Management System. 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. As a Specialist II, the individual will maintain and ensure compliance to Quality System programs.

The Life Science Quality Assurance Specialist II is a mid-level quality professional responsible in maintaining, quality system processes and programs to include: Supplier Quality, Investigation Systems, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA) management, training, and document review. In this role the candidate will work with cross functional teams aiding in root cause analysis, risk remediation and management. 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:

• 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.
  • Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures. 
• Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
• Perform compliance review on executed records from completeness of all required testing and documents for various processes.
• Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
• Identification of risk and risk mitigation 
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records. 
• Recognizes errors in records and resolves them in a timely manner.
• Perform other Quality Assurance Duties as required. 

Travel: 

Not applicable to Quality Specialist II | Onsite 5 days a week

Qualifications

Knowledge, Skills and Abilities:

• 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.

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. 

Education:

• Bachelors 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.

Experience

• 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

As an employee of CooperSurgical, youll 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.