What are the responsibilities and job description for the Documentation Specialist position at TalentBurst, an Inc 5000 company?
Documentation Specialist
Oceanside, CA
06 Months
Job Summary :
Responsible for owning and overseeing all Site Operations documents through creation and revision, the Site Operations Documentation Specialist helps to define and adhere to documentation guidelines by managing document change requests, working closely with technical collaborators, redlining documents, and ensuring timely completion of all Site Operations change records. Their knowledge needs to be deep in Site Operations bioprocessing, document revision, the Quality / GMP change control process, and project management capabilities.
- Job Responsibilities : Own and oversee the Facilities and Engineering document creation and revision process.
- Perform Change Owner responsibilities for Site Operations by managing process area and system change records including : quality actions, technology transfer changes, shutdown activities, inspection responses, and other Site Operations continuous improvements projects.
- Review all Site Operations revision requests and collaborate with technical experts and stakeholders to align on document revision prioritization, necessity, and improvement opportunities.
- Establish and implement business processes to optimize Site Operations document revision.
- Establish and implement documentation guiding principles that align with site training strategy, tech transfer readiness, and adhere to GMP regulatory requirements.
- Lead document revision teams and work streams, as necessary.
- Collaborate with Site Operations SMEs and technical assessors for document creation and revision.
- Redline documents using technical knowledge and knowledge of SOP's Act as Veeva and Eval Subject Matter Experts.
- Act as Site Operations Document Subject Matter Expert.
- Train others across the organization on document control processes and procedures, as necessary.
- Collaborate with Technical Training and Training Program Coordinators in the Site Operations Learning Group to develop training materials and align on training / documentation strategy and guiding principles.
- Utilize and maintain metrics and regularly solicit stakeholder and customer feedback to monitor document efficacy and look for continuous improvement opportunities.
- Improve right-first-time change initiation.
- Provide support to Site Operations Learning Group and GMP Services as required.
Education and Experience :
Bachelor Degree in Biological Sciences, Physical Sciences, Engineering is preferred
3 years' experience in a GMP facility. 3 years' experience revising GMP documents.
Commitment to achieve results is reached by applying hard work; understanding how to get things done through both formal channels and informal networks.
Ability to establish measurable goals, monitor and assess others performance and provide timely and relevant feedback, both positive and constructive.
Displays exceptional teamwork and collaboration skills. Strong verbal and written communication skills.
Work Environment :
