Document Control Specialist

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com.

• This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (i.e., H1B, STEM OPT extensions, TN, etc.)
• This position requires full-time onsite work (5 days per week) in Victor, NY and is not eligible for relocation assistance.

Job Summary:

Responsible for executing required QA review activities for change control elements associated with local and global departments in support of the Quality Management System.

Will revise and create Standard Operating Procedures (SOP’s), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts. Will utilize the Agile electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.

May participate in establishing procedures for local and global review of change packages as well as engineering changes, engineering studies, and validations when necessary.

May assist with the investigation of Quality Feedback (QFB’s), and Non-Conformance Reports (NCR’s) or other sources of quality data. May participate with packaging verifications and validations when necessary.

Experience:

• 3+ years of Quality Assurance or Document Control experience required, including experience with ECOs, DCOs, NCRs, QFBs, SOPs, and change control processes in a regulated environment.
• Medical Device industry experience preferred; other regulated industry experience considered

Education:

• HS diploma required
• Associates degree or equivalent combination of education and experience preferred

Knowledge, Skills and Abilities:

• Working of knowledge of Microsoft Office Suite. Experience with Agile preferred.
• Should possess skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce.
• Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices.

Work Environment:

• Normal Office environment
• Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task

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 U.S. locations that require disclosure of compensation, the starting base pay for this role is between $22.70 and $30.27 per hour and may include cost of living adjustments.  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.

#LI-AK1

• Act as change analyst for Document Change Orders (DCO’s) and Deviations for all controlled documents within assigned departments.
• Manages Training positions and roles in Agile for assigned local and Global departments.
• Provides QA oversight to Service Non-Conformances (SNC’s) generated by Customer Service.
• May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)).
• May assist with process audits to verify conformance with standard operating procedures. This will include revising and or creating SOP as directed.
• Regularly provides status and updates to QA Management.
• Generate or contribute to monthly reports provided to various departments and quality leadership as requested.
• Communicates information effectively from other departments to the QA team.
• Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.
• Data entry and analysis into computer-based collection systems (Access, Excel & Agile).
• Ensures that all necessary reports are completed in a timely manner.
• Performs archiving as necessary as it applies to quality records. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities.
• Perform or facilitate annual Quality Systems Regulation (QSR) retraining as required by the quality management system.
• As business needs dictate, works extended hours to complete daily department goals or tasks, to include mandatory overtime.
• Performs other assignments related to the department as directed by Leadership.
• Support Global Packaging and Global Supply Chain from QA review perspective for Packaging and New Product Launch Change Orders (PCO and NPLCO) and provide guidance on requirements to ensure compliance with change control regulations and CooperVision policies and procedures.

Travel Requirements:

Occasional (<5%) domestic and international travel.