Senior Technician, Quality Assurance
Core
Maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines by administering document control processes and maintaining quality systems documentation.
Role type
Senior Technician, Quality Documentation
Builds
Safe, effective, and high-quality animal health products (vaccines) for large and companion animals
Domain
Animal Health / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Compliance, Electronic Document Management Systems (EDMS), Standard Operating Procedure (SOP) Development, Standard Operating Procedure (SOP) Writing, Manufacturing Audits, Quality Management Systems (QMS), Process Improvements, Materials Inspection, Regulatory Compliance, Batch Record Management
Preferred skills
Document Control, Quality Systems, Regulated Manufacturing Environments, Quality/Biology/Microbiology Experience, Cell Culture Knowledge
Technologies
SAP, Microsoft Word, Microsoft Excel, MEDS
Responsibilities
Administer document control processes including creation, review, approval, issuance, revision, and archival of controlled documents; Maintain quality systems documentation such as SOPs, work instructions, forms, and batch records; Ensure documentation activities comply with GMP and regulatory requirements; Support document change control activities; Monitor documentation metrics and identify process improvement opportunities; Assist with internal and external audits and inspections; Maintain electronic document management systems (MEDS).
