QA Document Control Specialist II

American Regent, Inc. • Brea, CA

8d • $38 - $41

About The Position

Nature and Scope To perform, maintain and update logs and databases. Create and maintain controlled templates. Support document formatting. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Perform assigned controlled document lifecycle and records management processes in Veeva Document Management process. Manage proactive review program. Update and maintain logs and databases. Edit technical documents in accordance with formatting and template requirements. Writing and maintaining document control procedures and participating in the development and roll-out of document control tools. Scan, archive, manage controlled documents. Print and issue labels for production. Contribute to the development of training and deliver training, as needed. Write basic functional area SOPs. Archive and retrieve records as needed. Issue controlled documents. Create and issue/archive logbooks and notebooks as needed. Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor's Degree or equivalent experience, required.
• 3 years of experience in cGMP controlled or other regulated environment, required.
• GMP documentation management experience, required.
• Proficient use of Microsoft Office.
• Experience with Good Documentation Practices (GDP) and other applicable regulatory requirements.
• Strong organizational skills.
• Team and Customer Oriented.
• Experience with document management/records management software solutions.
• Experience using SharePoint and other business tools.
• Ability to work independently and multi-task in a fast, priority-switching environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Nice To Haves

• 3+ years in Pharmaceutical/Medical Device, preferred.

Responsibilities

• Perform assigned controlled document lifecycle and records management processes in Veeva Document Management process.
• Manage proactive review program.
• Update and maintain logs and databases.
• Edit technical documents in accordance with formatting and template requirements.
• Writing and maintaining document control procedures and participating in the development and roll-out of document control tools.
• Scan, archive, manage controlled documents.
• Print and issue labels for production.
• Contribute to the development of training and deliver training, as needed.
• Write basic functional area SOPs.
• Archive and retrieve records as needed.
• Issue controlled documents.
• Create and issue/archive logbooks and notebooks as needed.
• Perform any other tasks/duties as assigned by management.

Benefits

• American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level