Documentation Specialist - Change Control

Onsite Documentation Supervisor

Supervise the development, creation, and revision of controlled documentation in accordance with the client's policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establish partnerships with Managers and supervisors throughout local and global functions. Work with Change Control, Quality Investigations/CAPA team members, and other cross-functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues with minimal supervision. Serves as a representative for Quality Documentation and Change Control during regulatory audits. Fulfill the responsibilities and tasks of the Change Control Manager in their absence as well as be a team lead and provide guidance and direction to other team members.

Top 3 – 5 Skills Needed for each role:

• Technical Writing
• Change Management
• Records Management

Key Duties and Responsibilities:

• Author changes to controlled documentation, including but not limited to standard operating procedures, work instructions, batch records and forms. -25%
• Act as Initiator for Change Controls. Work with complex tasks and tight deadlines. Responsible for the execution of all steps to ensure timely completion of changes. -15%
• Act as subject matter expert in document creation, format and alteration as well as EDMS use. Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity. -10%
• Active member in cross-functional collaborative efforts, attends huddles, team meetings. Participates in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality, and other subject-matter experts to develop document content.
• Supports 5S methodology and ensures the area is safe and pleasant working environment. -10%
• Processes controlled documentation in the EDMS (Electronic Documentation Management System) in accordance with policies and procedures. -10%
• Reviews and evaluates change requests of varying complexity with minimal supervision. 5%
• Evaluates objective data associated with various change requests and follows up on activities required for closure. -5%
• Collaborate with internal and external customers. -5%
• Develop and implement process improvements regarding electronic document management system methods and provide training to support staff accordingly. -5%
• Represent Documentation and Change Control during regulatory audits-5%
• Communicates with management on a routine basis and escalates issues as needed. -5%

Education and Experience:

• Bachelor's degree, or 5-7 years equivalent experience.
• 3-5 years' experience in a technical writing position within a pharmaceutical, medical device or biotech company.
• In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.
• In-depth knowledge of EDMS (One Vault) and ERP System (SAP).
• Project Management capabilities.
• Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
• In depth knowledge of document authoring tools, including MS Office Suite.
• Demonstrated ability in proofreading and editing.
• Ability to multi-task and adjust to shifting priorities.
• Strong interpersonal skills including the ability to effectively work and actively communicate with people and cross-functional teams.
• Excellent oral and written communication skills as well as strong organizational skills.
• Strong analytical skills, with an eagerness to work hard and achieve exemplary results.
• Expert grammatical competency and writing skills.
• Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.
• Able to work professionally and courteously within a team environment sharing roles and responsibilities.
• Ability to provide training and guidance to initiators of change requests.