QC Documentation Specialist

Location: Hybrid, Needham, MA

Salary: $88k-$100k

Cross-functional support of relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). Also supports the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

• Administrate Document Management Program and provide support for document creation, revision, retirement.
• Review GxP documents and records for completeness and compliance with internal procedures and applicable regulations, ensuring ALCOA++ principles are followed.
• Support and manage document lifecycle in the Electronic Quality Management System (eQMS).
• Maintain and improve Document Management Program procedures.
• Provide training on the Document Management Program.
• Act as Administrator for Document Management within eQMS.
• Manage physical document archival and retention program.
• Administer the Training Management Program and provide support for maintenance of training activities.
• Maintain user roles, training curricula, and training assignments.
• Maintain and improve Training Management Program procedures.
• Provide training on the Training Management Program and Employee Onboarding Program related policies and procedures.
• Assist document owners in generating training materials and quiz questions.
• Act as Administrator for Training Management within eQMS.
• Additional duties: inspection readiness and execution tasks, internal audit support, deviation, CAPA, Change Control, and Supplier Qualification support, preparation of Quality Management System metrics, eQMS design and validation support, continuous improvement initiatives, and other responsibilities as assigned.

• BS/BA in a scientific or engineering discipline with 6+ years of experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure, or equivalent experiences.
• OR Associate’s degree in a scientific or engineering discipline with 8+ years of Quality experience or Quality (Assurance) exposure or equivalent experiences.

• Knowledge in 21 CFR Part 11, Annex 11, CFR 210, CFR 211, GxP practices.
• Knowledge of current regulatory and industry guidelines.
• Exposure to global health agency regulations.
• Internal audit/self-inspection experience.
• Experience in electronic Quality Management Systems.

• Proficient in Microsoft Office suite (Word, Excel, PowerPoint, Outlook, and Teams).
• Familiar with Smart Sheet and SharePoint platforms.
• Excellent written and oral communication skills.
• Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail in a rapidly changing environment.
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Highly motivated, ethical individual with excellent time management skills.
• Skilled at building consensus, securing stakeholder buy-in, and advancing strategic priorities in a matrixed organization.

Must be authorized to work in the US. We cannot provide sponsor ships.