Senior Life Science Quality Assurance Specialist

About the Company

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.

Responsibilities

• Maintain a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Provide Quality oversight, support, and engagement as needed by Operations.
• Own Quality Management System Processes, including:
  • Document Control Program: Review, approval, and maintenance of company Standard Operating Procedures via electronic Document Quality Management System. Ensure stakeholders adhere to company policies and templates.
  • Change Management Program: Review, approve, and track changes to approved procedures, validated software and processes, and qualified equipment. Review change task completion and facilitate cross-functional investigations to support closure of Change Control.
  • Deviations and Nonconformances: Review, approve, and monitor events and deviations. Handle complaints and investigations, and facilitate cross-functional team discussions to close Quality Events.
  • Supply/Vendor Management: Oversee supplier qualification, reassessment activities, quality agreements, and quality scorecards. Ensure processes are maintained and approved according to procedures.
  • Validations: Review and approve equipment, systems validation/qualification, and design transfers to operations.
  • Quality Metrics: Perform trending analysis and reporting of quality indicators. Identify risks and process improvements for operations. Facilitate meetings, provide system visibility, communicate status, and ensure closure of aging items. Gather performance metrics and coordinate Management review inputs. Track, trend, and report Quality System metrics to drive continuous quality improvements while communicating critical compliance and quality risks.
• Work cooperatively in a team environment to maintain cross-functional and cross-site process and procedural consistency for quality systems records.
• Create and implement a training program for QMS processes to educate Quality Assurance customers.
• Perform other Quality Assurance duties as required.

Requirements

• Understands and applies comprehensive knowledge of quality principles and maintains a current understanding of regulations.
• Familiarity or experience with the following is strongly preferred:
  • Basic statistics
  • Review/approval of documentation
  • Risk tools
  • Technical writing
  • Writing/reviewing/approving investigations
• Computer Skills:
  • Knowledge of Master Control or similar eQMS is a plus.
  • Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Adaptability: Responds effectively to changing constraints.
• Good interpersonal skills and ability to work effectively in a team environment.
• Understands drivers of change and anticipates implications of changing circumstances.
• Applies a preventative instead of corrective approach.
• Attention to detail: Checks information, identifies inconsistencies, and makes detailed comparisons.
• Positive work attitude supporting teamwork and continuous improvement.
• Decision Making:
  • Makes pragmatic decisions based on a range of factors.
  • Able to make decisions quickly with incomplete information.
  • Demonstrates logic to back up decisions.
  • Excellent critical analytical skills – ability to determine root causes of issues.
• Initiative:
  • Identifies ways to improve processes/situations.
  • Takes responsibility for improvements or solving problems.
  • Displays eagerness to learn and continuously improve.
  • Sets own standards above prevailing standards; dissatisfied with substandard or inefficient activities.
• Interpersonal Skills:
  • Socially capable – interacts confidently and reads situations effectively.
  • Empathetic and evaluates likely reactions.
  • Collaborative approach.
• Results Oriented:
  • Focuses on important issues.
  • Uses a risk-based approach.
  • Refocuses on results regularly.
  • Demonstrates drive to exceed performance targets.
• Task Management:
  • Handles multiple tasks and competing priorities concurrently and in a timely fashion.
  • Prioritizes and monitors task progress.
  • Makes realistic estimates of time and resource requirements.

Qualifications

• Bachelor’s degree (BA/BS) from a four-year college or university, or associate degree (A.A.) with four to six years of related experience and/or training, or six to eight years of related experience and/or training, or equivalent combination of education and experience.
• Candidates must demonstrate knowledge and proficiency in the Quality Assurance Specialist II role.
• Knowledge of regulations and standards such as:
  • AABB
  • AATB
  • FDA (HCT/P, cGMP, cGTP)
  • 21 CFR 1271
  • FACT
  • ISO 9001

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.

Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. Benefits include:

• Medical coverage
• 401(k)
• Parental leave
• Fertility benefits
• Paid time off for vacation, personal, sick, and holidays
• Multiple other perks and benefits

Pay

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $90,000 - $115,000. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.