Senior Quality Specialist (Contract)

• Serve as the point of contact for the Document Control system and quality-controlled records management.
• Support the development, enforcement, and improvement of policies, procedures, work instructions, templates, and forms related to document and records management.
• Collaborate closely with stakeholders (e.g., legal, clinical, regulatory, IT) to align record policies and lifecycles across platforms.
• Support centralized and decentralized quality-controlled record repositories (physical and electronic) for completeness, integrity, and retrievability.
• Support inspection readiness by ensuring all quality-controlled records are accessible, traceable, and compliant with data integrity and protection requirements.
• Support record audits, gap assessments, and remediation plans in preparation for regulatory inspections.
• Monitor, trend and report document control metrics (e.g., cycle time, overdue documents)
• Support internal and external audits and inspections.
• Provide guidance and training to system users and support documentation governance across departments.
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

• Perform document intake, advanced formatting, metadata review, routing, publishing, and obsoletion and ensure timely review, approval, and release.
• Support the management of periodic reviews of controlled documents.
• Advise document control participants on content and format to meet 4DMT procedural requirements, standards, templates, and best practices.
• Ensure compliance with document control procedures and applicable regulations.
• Collaborate with Quality Training to coordinate document and training lifecycles.
• Facilitate quality-controlled records management (e.g., onsite and off-site secure storage, retention, destruction)
• Identify and implement innovative methods to increase efficiency of operational tasks.

Education: 

• Bachelor’s degree required, preferably in a scientific, technical, or related field.

Experience: 

• 6+ years of experience in document control and records management within the biotech, pharmaceutical, or medical device industry
• 2+ years in a hands-on system and/or process ownership role for a GxP EDMS (e.g., ACE, MasterControl, Veeva, etc.).
• 2+ years leading or supporting GxP records management operations.
• Comprehensive knowledge of FDA, EMA, ICH requirements and industry best practices for document control and records management
• Practical experience leading or actively participating in at least 1 EDMS or EQMS system implementation and/or significant enhancement project.
• Exposure to audits and health authority inspections ideally in a commercializing biotech environment.
• Domain knowledge of clinical research and development, manufacturing, quality, and/or IT is highly desirable.

Skills: 

• Extensive experience in document formatting using MS Word.
• Solid working proficiency in other productivity tools (e.g., Outlook, Teams, SharePoint, Excel, PowerPoint, Forms, DocuSign, Adobe Acrobat).
• Basic knowledge of or willing to learn analytical and reporting tools (e.g., PowerBI).
• Foundational understanding of change management principles

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 - 20 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Hourly compensation range: $51.00 - 64.00

Please note, the hourly compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

• Excellent interpersonal communication skills both written and verbal.
• Highly organized with the ability to multi-task and perform effectively under pressure.
• Proven project management, problem-solving, and organizational skills
• Demonstrated ability to collaborate, influence, and negotiate effectively.
• Motivated to seek out training and mentorship for professional development.