Quality Control Lead Inspector

Maintain a visible Quality Operations presence on manufacturing floors and in clean rooms, providing timely guidance to operators, inspectors, and production leadership.

Perform routine floor and cleanroom walkthroughs to verify adherence to approved procedures, good documentation practices, gowning requirements, material and personnel flow, environmental controls, and line-clearance expectations.

Provide real-time quality oversight during manufacturing, assembly, inspection, packaging, and controlled-environment activities.

Monitor cleanroom conditions and practices, including environmental monitoring activities, microbial and particulate results, sanitation status, and response to excursions or adverse trends.

Escalate significant quality, safety, compliance, or product risks promptly and support decisions to pause work when established requirements are not met.

Perform incoming, in-process, final, and other product inspections as needed, using approved methods, drawings, specifications, sampling plans, and measuring equipment document results accurately.

Review executed production records, job orders, inspection records, logbooks, and supporting documentation for completeness, accuracy, and compliance facilitate timely correction of documentation errors.

Support product and material status decisions, including hold, quarantine, segregation, release readiness, and escalation to authorized Quality personnel.

Maintain orderly quarantine and controlled material areas and support effective transfer of information across shifts and facilities.

Initiate or support nonconformance, deviation, and batch records for issues identified during operations ensure immediate containment and preservation of relevant evidence.

Support investigations by gathering facts, reviewing records, interviewing personnel, assessing product impact, and supporting through closure.

Support product corrections and rework activities by helping define or review documented rework plans, confirming required appro

HSGED. 4+ years exp in Quality Control in the pharmaceutical, biopharma or medical-device industry. Supervisory or lead exp. ISO 13485 or ISO 9001 exp.

Bachelor or Associate degree in quality, life sciences, engineering, manufacturing, or a related technical field. Syteline ERP and QT9 electronic quality management software.