Quality Assurance Associate
Core
Provide quality support for the manufacturing of solid oral dosage products by reviewing documents, monitoring activities, and testing samples.
Role type
Quality Assurance Associate (Manufacturing)
Builds
Solid oral dosage forms (tablets and capsules) for pharmaceutical and consumer health programs
Domain
Pharmaceutical manufacturing / Oral solid dose technologies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record auditing, environmental monitoring, routine product testing, deviation reporting, root cause analysis, inventory management, technical writing, documentation accuracy
Preferred skills
Lean Six Sigma, ASQ certification, continuous improvement techniques
Technologies
TrackWise, JD Edwards
Responsibilities
Recommend and review Standard Operating Procedure changes; Conduct real-time audits of batch records; Perform room and equipment clearances; Perform environmental monitoring via microbial swabbing; Test in-process and finished product samples; Monitor manufacturing areas for compliance; Identify and resolve routine errors; Initiate deviation reports; Manage quality status of work-in-process and finished goods; Support investigations and gather data; Investigate customer complaints; Provide training to manufacturing personnel.
Seniority
Entry-level to Mid-level, hands-on IC
