|Title:||Document Control Specialist, Quality Assurance|
VenatoRx Pharmaceuticals, Inc., a private, clinical-stage pharmaceutical company located in Malvern, PA, has an opening for a Document Control Specialist on our Quality team. We are looking for passionate, motivated, and intellectually curious professionals to join us as we continue in our pursuit to discover and develop new medicines to treat drug-resistance infections.
The Document Control Specialist, QA is responsible for the collecting, maintaining, and distributing all documents necessary to support Quality Management System, drug development and Regulatory filings. This person will format, file, archive, and maintain all documentation generated or required across various products and the company, including Standard Operating Procedures (SOPs), Forms, Validation documentation, and source files.
- Perform day-to-day Document Control activities: Process DCR packages and review for correctness and completeness; monitor and update in-process documents/logs; create, assign and archive QA controlled source documents and reports; assist in managing the electronic document repository.
- Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval.
- Participate in internal and external audits
- Participate in regulatory inspections
- Issue/track the training of GXP procedures for new and existing employees
- File and track internal/vendor deviations, investigations, and change controls
- Provide user assistance with using the document repository and document management system
- Provide user assistance in in preparation/revision of GXP controlled documents (SOPs, Specifications, Forms, etc.)
Successful candidates will be able to demonstrate:
- Bachelor's degree with 2 years of general document control experience
- 2-5 years of pharmaceutical experience in a GMP environment
- Minimum of 2 years' experience using and administering electronic document management tools; previous experience implementing an electronic document system a plus
- General knowledge of electronic documentation systems, data retrieval, and electronic file formats
- Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable
- Willing to learn new areas of responsibility
- Ability to work independently and cross-functionally
- Ability to work effectively in a team environment
- Ability to analyze and reconcile moderately complex issues
- Must have demonstrated initiative and accountability in a fast-paced environment
- Excellent verbal and written communication and interpersonal skills
- Proficient with computers and word processing software (i.e. Microsoft Office products)
- Excellent Microsoft Word skills, including the use of heading styles