Quality Assurance Specialist I

Job Description

Job 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.

Duties and Responsibilities:

• 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 Product 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.