Document Control Administator

Integer Holdings; Plymouth (MN); On-site; USD 33,875 - 49,690; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid time off

Job summary

Integer Holdings is looking for an administrative professional in Quality to support documentation activities in compliance with GMP and FDA standards. The ideal candidate has 3-4 years of experience and strong skills in communication, organization, and problem-solving. In this role, you will ensure adherence to Quality Management Systems and assist with audits and training.

The position offers competitive hourly pay and a comprehensive benefits package, including medical, dental, and a 401(k) plan with company matching.

Qualifications

• Minimum 3-4 years of experience in an administrative role.
• Capable of working under minimal supervision.
• Proficient understanding of Quality Management Systems.

Responsibilities

• Support documentation administration activities within Quality.
• Control distribution and retrieval of documents.
• Assist the Quality department during audits.

Skills

Leadership

Effective communication skills

Strong organizational skills

Attention to detail

Problem Solving

Education

Diploma or equivalent in administration

Tools

Microsoft Teams

Excel

Word

Job description

What you will do in this 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. Carries out responsibilities under clearly defined procedures and / or under minimum supervision.

• 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.
• Assist 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.

Grow on the job and help others succeed

Expands skill base through on-the-job training, cross training, and classroom instruction.

Ensure Alignment on the Corporate Strategic Initiatives

• Continually seeks to drive improvements in process quality.
• Identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics.
• Adheres to Integer Core Beliefs, Safety and Quality requirements and applicable regulations described in the quality management system (QMS).
• Embed Quality within your daily work life - \"I own Quality.\" You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS).

How you will be measured

• Safety is our highest priority; you are an active supporter of the Integer Environmental, Health & Safety programs.
• Live the Integer Values through leading by example.
• Assist the site in achieving its annual goals for safety, quality, delivery, cost, and inventory.
• Achieve all Goals and Objectives assigned.

What sets you apart

• Minimum Education: Diploma / or equivalent in administration preferred.
• Minimum Experience: 3-4 years of experience. Developed specialized skills in their area and other related areas. Capable of working under minimum Supervision.
• Special Skills:
  • Leadership
  • Provides informal guidance and support to junior team members and other users.
  • Effective communication skills (both oral and written)
  • Responsible for explaining technical information or data.
  • 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
  • Capable of providing solutions to problems in situations that are infrequently occurring.
• Specialized Knowledge: Proficient Understanding of Electronic documentation systems, Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820), and Office Management and Administration skills.

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

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.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.