Provides routing quality assurance support related to the development of client’s Quality Management System. This includes but is not limited to: maintaining the audit program schedule, review of audit reports and producing observation reports from same, supporting the maintenance of the document control system and GXP training program while ensuring adherence with checking standards and regulatory guidelines. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. Understands and demonstrates the ability to perform moderately complex document control processes. Provides proposals for continuous improvement and may support implementation. Normally receives no instruction on routine work and receives instructions on new assignments.
- Supports the auditing program by assigning audit numbers, developing observation reports to be sent to vendors, ensures audit certificates are issued for audits, follows up with vendors for responses to audit findings, revises standard operating procedures (SOPs), Forms and work instructions for continuous improvement of documentation systems.
- Provides administration and troubleshooting support (i.e. general to moderately complex) for the Electronic Document Management System (EDMS). Provides internal technical support and escalates as appropriate to EDMS vendor’s technical support
- Analyzes document changes for completeness. Ensures the correct and timely implementation of document control requests, by tracking workflows in EDMS. Verifies own work, checks format and compliance with company templates.
- Performs advanced word processing support and assists Client personnel in resolving document format issues.
- Ensures data integrity and security of all databases and documents containing data relevant to product quality and/or Quality Systems processes.
- Supports the maintenance and contributes to the continuous improvement of document templates.
- Supports and maintains archival of offsite storage
- Supports the document periodic review process.
- Supports the collection and maintenance of department metrics.
- Participates in the development of training materials.
- Provides support to internal and regulatory audits and inspections as required.
- Applies company policies and procedures to resolve a variety of moderately complex issues. Exercises good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action.
- Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
- Follows Environmental, Health, and Safety (EH&S) policies and procedures. Takes responsibility for safety in the immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.
- Performs other related duties and assignments as required and defined by management.
- Five to eight years of quality assurance and document control experience in the pharmaceutical/biotech industry.
- Works under minimal supervision; showing a level of independence.
- Typically, a BA/BS or equivalent combination of related education and experience.
Preferred Additional Skills:
- Excellent knowledge of understanding of Document Control standards, practices, and principles.
- Excellent knowledge of understanding of Quality Systems and applicable GMP regulations and standards.
- Demonstrates the ability to perform detail-oriented work with a high degree of accuracy.
- Effective written and oral communication skills.
- Effective time management and interpersonal skills.
- Possesses initiative and is proactive.
- Experience with databases and is proficient with the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
- Excellent organizational and planning skills.
- Must work effectively within teams with rapidly changing priorities.
- Builds productive internal and external working relationships.
- Demonstrates good coping skills and analytical problem-solving skills.
- Document storage and retrieval may require lifting boxes of documents, carrying documents from one place to another and storing boxes on shelves or in file cabinets.
- Handling documents requires repetitive motion using a variety of scanning and computer equipment.
- Should have good keyboarding skills and manual dexterity.