Job Description

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.

• Knowledge, Skills and Abilities 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 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.

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:

• Work in a standard office environment.
• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots must be worn. Also, no make-up or jewelry can be worn when working in the clean room environment.
• When working in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
• Also may work a schedule that could include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
• May climb upwards of 6 flights of stairs a day to maneuver within the Site Operations facility.
• Lifting up to 25lbs may be required.
• May work with hazardous materials and chemicals.

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