Life Science Quality Assurance Specialist III

Job Summary

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The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. In this role the candidate will mentor and train new personnel on the Quality System(s). The Quality Specialist III will partner with stakeholders to improve the quality program and quality culture within the organization. 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.

• Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.

• Provide Quality oversight, support and engagement as needed by Operations.

• Owner of 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.

Reviews chart and records for completeness of all required testing, specifications and documents for various processes.

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.

• Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.

• Gather performance metrics and coordinate Management review inputs from various contributing departments.

• Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.

• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.

• Create and implement a training program for the QMS processes to educate Quality Assurance customers.

• Perform other Quality Assurance Duties as required.

Travel: Less than 5%

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:

• Bachelor’s degree (BA/BS from four-year college or university or associate degree ( with four to six years related experience and/or training.

• OR six to eight 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 III role

• Candidates should demonstrate knowledge of regulations and standards such as:

CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories

AABB, Canadian CTO, FDA (HCT/P, cGMP, cGTP), 21CFR1271, and ISO 9001 regulations

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Our Benefits:

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 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.

For . locations that require disclosure of compensation, the starting base pay for this role is between $80,000.00 - $95,000.00 CAD. 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.