QA Documentation Specialist

Job Summary:

This position is responsible maintenance and compliance of the Documentation Management System and for implementing systems in place to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems. 

Responsibilities & Duties:

• Reviews and edit new QA controlled documents to ensure compliance with format requirements as per the Document Management System. 
• Responsible for issuing and tracking document change requests (DCR) and for ensuring that changes to approved documents clearly reflect what has been included in the DCR.
• Routes and controls all documents going to the approval process ensuring all required signatures are obtained. Works with originators and approvers to ensure company timelines are met.
• Responsible for control and maintenance of document master files and for filing all other QA controlled documents.
• Responsible for issuing batch production records and for tracking issued to and received from manufacturing and QC, as well as tracking records returned for corrections to ensure records are promptly located and do not get lost.
• Complies with company safety policies and minimizes risk to self, others and the environment, consistent with the community and industry standards.
• Actively pursues corporate timelines and milestones set by the department director and upper management.

Requirements:

Qualified candidates should hold a BA/BS or have equivalent industry experience, with a minimum of 1 to 2 years of experience working in the biotech or medical device industry in document control or Quality Assurance role.  Attention to detail and proficiency with Microsoft Word, Acrobat, Excel, and PowerPoint is required, with knowledge of databases or Electronic Document Management Systems a plus.  Basic knowledge of document control fundamentals, Quality Systems and GMP requirements is necessary.  Candidates must be able to demonstrate good analytical problem solving skills, good verbal and written communication skills, and the ability to work calmly and effectively in a fast paced, dynamic environment.