Quality Assurance Document Control

Job Summary We are seeking a detail-oriented and proactive Quality Assurance Document Control specialist to join our team. In this vital role, you will oversee the management, organization, and integrity of quality documentation to ensure compliance with industry standards and regulatory requirements. Your expertise will support our commitment to delivering high-quality products and services by maintaining accurate records, streamlining document workflows, and fostering a culture of continuous improvement. This position is responsible for managing and administering the Document Control systems to ensure compliance with applicable internal procedures, review and filing batch records, and cGMPs. Responsibilities Strong organizational skills with the ability to manage multiple documents simultaneously while maintaining accuracy. Assist in the preparation of cGMP documents for transition into a new electronic document management system. Propose and assist in the implementation of quality improvements to document control systems. Review, issuance, and closure of Document Change Controls in accordance with Catalent's SOPs for all quality documents (i.e., Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.). Audit SOP controlled files and SOP matrix for accuracy against CDMS System information. Audit Batch Record Suspension log to determine which Suspensions can be closed and driven to closure. Creation, distribution, closure and filing of logbook in tracker. Suspension paperwork organization and filing + Assist in the creation of training materials for job aids to make on-boarding training more robust and efficient. Creation of a trace-ability system for PDF renditions of controlled documents with respective source files visibility. Update databases (i.e., logbook tracking database) to align with off-site storage records to ensure prompt and fluid retrieval of controlled documents and records. Reduce risk by assisting in timely closure and filing of batch record suspensions.

Requirements:

Excellent interpersonal/communication skills. Attention to detail. Strong written communication skills Time management skills Collaboration skills Will be working in an office environment: must be able to use computer and accessories. May need to work with others in different parts of the buildings (including Manufacturing and Fulfillment) in which the environment could be different - noise, dust, concrete floor, etc. Must be able to use traditional office equipment; should be able to sit, stand, reach overhead, bend, twist, stoop, lift up to 10 pounds.

Pay:

$21.00 - $24.00 per hour

Benefits:

401(k) 401(k) matching AD&D insurance Dental insurance Disability insurance Employee assistance program Health insurance Health savings account Life insurance Paid parental leave Paid time off Vision insurance

Work Location:

In person