QA Document Control Admin - Decatur, United States - Fagron GmbH & CO. KG

Description

Over de functie

The Document Control Admin & Trainer is responsible for maintaining organized and updated GMP-related documents.

Their duties include using document management software to upload or scan paper documents, retrieving documents for authorized personnel and ensuring document storage to comply with in-house procedures and federal regulations.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Scan and retention of all GMP-related activity documents.
• Quality review of Certificates of Conformity of sterile supplies to include Letco Lot and Item information, quality digital signature and upload to the Customer Relationship Management system.
• Fulfill all applicable document requests from Letco Account Managers and customers.
• Periodic review and documentation of all Document Control Room files for disposition (retention, off-site storage, destruction, etc.).
• Creation, issuance, and archiving of all site logbooks.
• Assist in developing and revising standard operating procedures (SOPs).
• Assists in investigations of internal quality issues.
• Performs/assists with customer/supplier complaint investigations and drafts customer response letters for approval.
• Distributes associate training status reports to appropriate Department Manager.
• Performs new hire quality training and other quality training sessions, as required.
• Ensures all new hire and on-the-job training documentation forms are completed and submitted to Document Control in a timely manner.
• Maintaining organized and updated employee training files.
• Supports all regulatory and third-party audits of the facility.
• Other duties as required.

Wat wij vragen

Basic Qualifications

• High School Diploma and/or General Education Degree (GED) required; associate or bachelor's degress in science related field or industry-equivalent experience preferred; minimum of two (2) years of progressive responsibilities in an administrative role or document experience preferred; or an equivalent of education and experience.

Experience in the pharmaceutical industry is a plus.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions.

• Advanced knowledge of the Microsoft Office suite of applications including Word, Excel, PowerPoint and Outlook and Edge.

Experience with electronic document control systems and electronic quality management systems preferred.

Wat wij bieden

We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success.

Our benefits include, but are not limited to:

• Competitive Compensation and Monthly Bonus Program
• Health, Vision, and Dental Insurance
• Company Paid Life Insurance
• Generous Paid Holidays
• Paid Volunteer Time
• Generous Paid Time Off and Rollover
• Company matching 401K and Retirement Savings Plans
• Employee Assistance Program

Over het bedrijf

Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide.

As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field.

Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.

If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Letco Medical, a Fagron Company, that you'll love Together we create the future of personalizing medicine.

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