Document Control Specialist

The Cooper Companies • Victor, NY

55d

About The Position

CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com. 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. 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. VICTOR - Specific Additional Functions 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. HENRIETTA - Specific Additional Functions Administers lot blocking process Travel Requirements: Occasional (<5%) domestic and international travel.

Requirements

• 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.
• 3 years of experience with document control (ECO, DCO, NCR, QFB, and SOP or equivalent) required
• HS diploma required

Nice To Haves

• Medical Device industry experience preferred; other regulated industry experience considered
• Associates degree or equivalent combination of education and experience preferred

Responsibilities

• Responsible for executing required QA review activities for change control elements associated with local and global departments in support of the Quality Management System.
• 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.
• Utilize the Agile electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.
• Participate in establishing procedures for local and global review of change packages as well as engineering changes, engineering studies, and validations when necessary.
• Assist with the investigation of Quality Feedback (QFB's), and Non-Conformance Reports (NCR's) or other sources of quality data.
• Participate with packaging verifications and validations when necessary.
• 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.
• Assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)).
• 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.
• Administers lot blocking process

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees