Associate Document Control Administrator

Integer • Alden Plant Alden, NY

13h

About The Position

The Associate Document Control Administrator supports and performs documentation administration activities within the Quality function, following Good Manufacturing Practices (GMP), Quality system guidelines, and clearly defined procedures, generally under close supervision. The role administers change records, manages controlled document distribution and retrieval, controls access to records, conducts annual record disposition reviews, compiles and reviews quality documentation, and assists with audits. The administrator also supports continuous improvement, helps identify and escalate quality non-conformances, and adheres to applicable company policies, safety requirements, regulatory requirements, and the Quality Management System (QMS).

The position provides data to other departments and develops skills through on-the-job training, cross-training, and classroom instruction. Success is measured by supporting safety, quality, delivery, cost, and inventory goals; achieving assigned objectives; and demonstrating Integer’s values.

Requirements

• High school graduate or equivalent may be required.
• 0–1 years of experience; entry-level administrative duties.
• Ability to work under close supervision.
• Effective oral and written communication skills.
• Strong organizational skills, including time management, prioritization, and meeting deadlines.
• General computer operation skills, such as Microsoft Teams, Excel, and Word.
• Attention to detail when reviewing and preparing documents.
• Ability to use existing procedures to solve problems and engage in continuous improvement activities.
• Basic understanding of electronic documentation systems.
• Basic understanding of Quality Management Systems, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
• Office management and administration skills.
• Adherence to applicable safety, quality, regulatory, and company requirements.

Responsibilities

• Provide administrative support for change record implementation in accordance 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 reviews.
• Compile and complete quality records, reports, and documentation while applying Good Documentation Practices (GDP).
• Review Device History Records (DHR) in accordance with applicable procedures and Good Documentation Practices.
• Assist the Quality department during audits.
• Provide data to other departments.
• Continually seek improvements in process quality.
• Identify and escalate quality non-conformances to support company quality objectives and key business metrics.
• Adhere to company policies, safety and quality requirements, applicable regulations, and the QMS.
• Support Integer Environmental, Health & Safety programs and contribute to site goals for safety, quality, delivery, cost, and inventory.
• Expand skills through on-the-job training, cross-training, and classroom instruction.
• Perform other duties as required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Adoption benefits
• Parental leave available after one year
• 401(k) plan with company matching contributions, with immediate eligibility
• 80 hours (10 days) of company-designated holidays per year
• Annual allotment of paid time off
• Cash-based incentive program
• Overtime pay, shift differentials, and call-in pay when applicable
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED