Site Operations Documentation Specialist

Russell Tobin is seeking a Site Operations Documentation Specialist for a biotechnology company that is known for developing medicines for life-threatening diseases.Job Title: Site Operations Documentation SpecialistLocation: Oceanside, CA 92056 (on-site)Job Type: ContractLength: 6-monthsEst. Start Date: February 25, 2025Hours: 40 hours/week. Mon-Fri. 1st Shift.Pay Rate: $36.00 - $41.02 per hourJob 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'sAct 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 SiteOperations 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 preferred3 years' experience in a GMP facility.3 years' experience revising GMP documents.Knowledge, Skills and AbilitiesStrong technical knowledge of GMP, SOPs, compliance and safety requirements within a biochemical-Site Operations environmentStrong technical knowledge of the biopharmaceutical Site Operations process and equipment.Expertise in redlining Site Operations documents.Expertise in Condor and Trackwise.Working knowledge of regulatory requirements.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.Benefits that Russell Tobin offers:Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.Apply Today! If you are interested in the position, please email your resume to rob.vanriet@ for immediate consideration.

Created: 2025-02-14