What are the responsibilities and job description for the Documentation Specialist position at The Mom Project?
For more than 40 years, our Customer has been following science and seeking solutions to unmet medical needs. They are a biotechnology corporation that makes medicines to treat patients with serious medical conditions. Their goal is to use the power of genetic engineering and advanced technologies to make medicines that address unmet medical needs, and help millions of people worldwide.
We are seeking a Documentation Specialist on a contract basis to support our customer's business needs. This role is onsite in Oceanside, CA during training phase and can be hybrid (3 days onsite) afterwards.
This role will be 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.
Responsibilities
Perks are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)
Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
We are seeking a Documentation Specialist on a contract basis to support our customer's business needs. This role is onsite in Oceanside, CA during training phase and can be hybrid (3 days onsite) afterwards.
This role will be 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.
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.
- Bachelor's degree in Biological Sciences, Physical Sciences, Engineering is preferred
- 0-3 years’ experience in a GMP facility highly desirable
- 0-3 years’ experience revising GMP documents highly desirable.
- Strong technical knowledge of GMP, SOPs, compliance and safety requirements within a biochemical-Site Operations environment
- Strong technical knowledge of the biopharmaceutical Site Operations process and equipment.
- Expertise in redlining Site Operations documents.
- Expertise in Condor, Veeva and Trackwise preferred.
- Working knowledge of regulatory requirements preferred.
- Strong technical writing ability.
- Strong planning and organizational skills and ability to manage multiple priorities at the same time.
- Able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners.
Perks are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)
Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
