Job Description

Job Title: Documentation Specialist

Location: 4038 Avenida De La Plata, Oceanside, CA 92056

Job Summary:

The Documentation Specialist is responsible for managing and overseeing all Site Operations documentation, ensuring compliance with GMP standards and internal quality guidelines. This role involves coordinating document revisions, managing change requests, collaborating with technical teams, and improving documentation processes. The ideal candidate has a strong background in bioprocessing, GMP compliance, and project management.

Key Responsibilities:

Document Management & Compliance

• Own and manage the creation, revision, and approval of Facilities and Engineering documentation.
• Serve as the Change Owner for Site Operations, handling process updates, system modifications, technology transfers, shutdown activities, inspection responses, and continuous improvement projects.
• Review document revision requests, collaborating with technical experts to prioritize and implement necessary updates.
• Ensure documentation aligns with GMP regulatory requirements, training strategies, and tech transfer readiness.
• Act as the Site Operations Document Subject Matter Expert (SME), providing guidance and support to stakeholders.

Process Improvement & Collaboration

• Develop and implement business processes to optimize document revision workflows.
• Lead document revision teams and workstreams as needed.
• Work closely with SMEs and technical assessors to create and update documentation.
• Utilize technical expertise to redline documents and ensure accuracy.
• Act as a Subject Matter Expert for Veeva and Eval document management systems.
• Collaborate with the Site Operations Learning Group to develop training materials and align documentation with training strategies.
• Monitor document effectiveness through metrics, stakeholder feedback, and continuous improvement initiatives.

Training & Support

• Train employees on document control processes and best practices.
• Support the Site Operations Learning Group and GMP Services as needed.

Qualifications:

Education & Experience

• Bachelor’s degree in Biological Sciences, Physical Sciences, Engineering, or a related field (preferred).
• Minimum of 3 years of experience in a GMP facility.
• Minimum of 3 years of experience revising GMP documents.

Technical Skills & Knowledge

• Strong understanding of GMP regulations, SOPs, compliance, and safety standards in a bioprocessing environment.
• Expertise in document redlining and management.
• Proficiency in Condor and Trackwise document control systems.
• Strong technical writing and editing skills.
• Working knowledge of biopharmaceutical processes and equipment.

Soft Skills & Abilities

• Excellent planning and organizational skills with the ability to manage multiple priorities.
• Strong verbal and written communication skills.
• Ability to collaborate effectively across teams and build relationships with stakeholders.
• Proactive problem-solving and process improvement mindset.

Work Environment & Physical Requirements:

• Standard office setting with occasional work in a cleanroom environment.
• Cleanroom work requires specialized gowning (scrubs, bunny suits, gloves, steel-toe boots) and prohibits jewelry or makeup.
• Exposure to loud mechanical equipment, high-pressure steam, and chemical materials.
• May involve a non-traditional schedule, including 10-hour shifts, evening/night shifts, or weekend work.
• Frequent stair climbing (up to six flights per day) within the facility.
• Lifting up to 25 lbs as needed.

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