Document Control Specialist

Description

Position Summary:

The Quality Assurance Document Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Bell International Laboratories approved procedures and output documents are accurate. The individual will assist in the day-to-day record management activities within Bell Labs complying with company and regulatory requirements.

Responsibilities

• Perform QA document control functions, including document login, tracking, processing, review, distribution, release and archiving of documents.
• Coordinate the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring area managers perform annual review of all cGMP documents and SOPs.
• Confer with document originators to resolve discrepancies and compiles required changes to documents
• Organize and ensure accurate and reliable filing systems for GMP documents.
• Create and maintain Certificates of Analysis’ for customers
• Maintain in house training programs including training matrix, training files and annual audit of training files.
• Maintain key aspects of the quality system such as: IQOQ, document control, CAPA, Change Control, Deviations, OOS’s, Annual Product Review, and others
• Actively participate in internal audits, customer audits and other activities as assigned by manager.
• Create Annual Product Reviews for all OTC products. 

Required Skills/Abilities

• Knowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handling 
• Proficient at reviewing and editing documentation
• Familiar with cGMP’s and the ability to follow standard operation procedures
• Excellent written, verbal and interpersonal communication skills
• Strong critical thinking and problem-solving skills
• Ability to prioritize multiple responsibilities and manage deadlines accordingly. 
• Communicate effectively with all members of organization and all levels of management
• Exceptional attention to detail and high level of accuracy & organization
• Ability to work independently with minimal supervision in a fast-paced environment
• Ability to adapt quickly to changing policies and procedures
• Exhibit a quality mindset and a willingness to develop yourself and others.
• Proficient with Microsoft Office and Adobe Acrobat

Requirements

Required Education and Experience

• Associates degree in scientific discipline
• 2-5 years of hands on experience with document management in a regulated industry–pharmaceutical or medical device industry–with direct document control experience.

Preferred Education and Experience

• Bachelor’s degree in scientific discipline 
• Audit or inspection experience
• Demonstrated knowledge of cGMP’s, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.