Document Control Administator

About the role

The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines.

Responsibilities

• Adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required in your location.
• Provide administrator support for change record implementation in line with standard operating procedures.
• Control distribution and retrieval of documents including electronic files of controlled documents.
• Notify applicable functions when local external documents change (as required).
• Manage and control access to on-site and off-site records and documents.
• Perform annual record disposition review.
• Compile / complete quality records, reports and / or documentation ensuring Good Documentation Practices (GDP) are applied.
• Review Device History Record (DHR) in accordance with applicable procedures and Good Documentation practices.
• Aid the Quality department during audits.
• Provide support / guidance and analysis to other departments.
• Train personnel in proper techniques to utilize systems, and processes.
• Performs other duties as required.

Qualifications

• Developed specialized skills in their area and other related areas.
• Capable of working under minimum Supervision.

Skills

• Leadership
• Effective communication skills (both oral and written)
• Strong organizational skills (including time management and ability to prioritize and meet deadlines)
• General computer operation skills (e.g., Microsoft Teams, Excel, Word)
• Attention to detail when reviewing and preparing documents.
• Problem Solving

Benefits

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base wages, a cash-based incentive program supporting our pay-for-performance philosophy, overtime pay, shift differentials, and call-in pay, when applicable. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Pay

Salary range for this position is $24.59-$36.07 per hour

Schedule

N/A