Quality Assurance Specialist I (Document Control)

Quality Assurance Specialist I (Document Control)

Kelly is hiring a QA Specialist I Document Control for one of our clients in Rockville, MD.

$23.50/hr PR

Immediate availability needed.

Role is onsite 5 days per week. M F, 8:30 am 5 pm ET.

Temp to hire

Minimum of 2+ years of relevant experience.

A bachelor's degree is preferred.

Position Summary:

The QA Specialist I Document Control is responsible for managing all controlled GMP documentation in compliance with internal procedures and policies, as well as regulatory requirements. The QA Specialist I establishes and maintains a system for the archival, retrieval, retention, and destruction of controlled documentation.

Key Responsibilities and Duties:

• Serve as the second level approver for controlled documents for verifying if documents meet the internal document template requirements
• Issue, reconcile, and file Batch Production Records in a timely manner
• Issue, reconcile, and file logbooks in a timely manner
• Issue approved forms (as required) in a timely manner
• Maintains document templates, project tracking logs, and databases through standard electronic formats
• Scans, uploads, and archives completed and reviewed controlled documents that are identified to be retained by QA in their appropriate locations
• Controls if the effective version of documents are available at the point of use
• Update SOP satellite binders as documents become effective
• Responsible for supporting client and regulatory audits
• Contributes to the overall management of client specific documentation
• Monitors retention periods for controlled documentation and communicates with clients for documents reaching their retention period as defined in the Quality Agreement
• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements
• Provide technical assistance throughout the document initiation, review, and approval process
• Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices
• Participates in continuous improvement initiatives within scope of work
• Coordinates off site archival activities including interaction with off-site archive facilities for data storage and retrieval, as required
• Actively participates in all recruiting efforts to secure, onboard, and develop new staff members
• Ensure the Document Control room is in order (6S)
• Assist in compiling Document Control performance metrics
• Format Word documents
• Additional duties as assigned

Qualifications:

• Bachelor's degree, preferred
• Minimum 2+ years of relevant experience in a similar position
• Experience in managing paper based and electronic based document management systems in commercial pharmaceutical/ biopharmaceutical manufacturing and GMP environment
• Experience in electronic document management systems. Experience in Pilgrim is preferable
• Strong verbal and written communication skills as well as technical writing and documentation skills
• Strong organizational skills; able to prioritize and manage through complex processes/projects
• Ability to perform and complete task independently
• Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint)
• Ability to follow instructions and Standard Operating procedures
• Ability to always maintain a professional and pleasant demeanor