Position Summary:

Support Quality Assurance Document Control functions, with a specific focus on filing, scanning, organizing, and reviewing GMP records. 

Responsibilities: Including but not limited to:  

• Assist with the retention and organization of all GMP documents.
• File, scan, and index related GMP documentation.
• Retrieve GMP documents in response to requests from all departments.
• Maintain and improve document logs and the filing system.
• Support intercompany communication and document retrieval requests.
• Review GMP records for accuracy and compliance with Standard Operating Procedures (SOPs).
• Other responsibilities as assigned by senior leadership team. 

Education and Experience:

• High school diploma; some college coursework or an associate degree is a plus.
• Previous work experience, preferably in an FDA-regulated industry.

Skills, Abilities and Knowledge:

• Strong communication and strategic-thinking skills.
• Proficient in using MS Office programs and ERP systems such as Aurantium, and other document management and business communication tools. 
• Ability to multitask, prioritize and manage time effectively.
• Some knowledge of cGMPs related to US FDA and manufacturing environments

Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• May be required to lift up to 50lbs, stand, bend, climb stairs. 
• Specific vision abilities required include close vision, ability to focus. 
• Requires the ability to climb stairs as part of regular duties, including accessing multi-level facilities or transporting documents between floors. 

Work Environment:

• Required to be present in the office to collaborate with peers and supervisors. 
• Work/Travel schedule must be adhered to and/or changed as needed to meet business requirements. 
• Potential ongoing travel throughout geographic areas on a continual basis as normal scope of role.

Supervisory Responsibilities:

• None

Personnel Protective Equipment or Attire Required for Position:

• As needed