Sr Associate II, Technical Quality
Core
Lead quality investigations, change controls, and regulatory compliance oversight for manufacturing, laboratory, and engineering operations in biotech/pharma.
Role type
Senior Technical Quality Associate (cGMP)
Builds
Quality assurance oversight for QC operations, technology transfers, and material management
Domain
Biotechnology / Pharmaceutical Manufacturing / Quality Systems
Deliverable
client delivery
Required skills
Deviation investigation, root cause analysis, change control management, process validation, regulatory compliance (FDA/EMA), data integrity, GMP expertise
Preferred skills
Regulatory inspection support, technology transfer, raw material release testing, Quality Control operations
Technologies
Laboratory information management systems (LIMS), analytical instruments
Responsibilities
Lead and approve deviation investigations; Assess deviation impact and support CAPA; Manage change controls for materials and suppliers; Provide QA oversight of QC and lab systems; Review OOS/OOT/invalid lab results; Perform material disposition; Support audits and regulatory inspections; Provide technical guidance on GMP compliance
Seniority
Senior, hands-on IC
