Teams at BioPharma Consulting JAD Group

Supports pharmaceutical quality control operations through routine and non-routine HPLC, UPLC, and microbiological testing; data review and trending; investigations; lab equipment and inventory maintenance; method transfers and validation; controlled document updates; and regulatory inspection readiness. The role requires GMP and GLP compliance, weekend lab coverage, cross-functional collaboration, and support for continuous improvement initiatives.

Leads remediation and improvement of metrology and calibration programs in regulated manufacturing environments. Conducts gap assessments, CAPAs, audit responses, risk-based impact assessments, out-of-tolerance evaluations, and calibration governance improvements. Applies dimensional metrology, measurement uncertainty, tolerance analysis, traceability, guard banding, and statistical analysis using Minitab. Authors quality documentation, supports audits, evaluates manufacturing and inspection equipment, manages remediation timelines, trains personnel, and coordinates improvements across engineering, manufacturing, validation, laboratory, and quality teams.

Performs analytical testing and visual inspections for raw materials, in-process samples, finished products, environmental samples, and stability batches. Investigates atypical and out-of-specification results, conducts trend analysis, and supports product release. Develops, validates, and transfers analytical methods; maintains instruments, SOPs, documentation, and compliance records. Coordinates with vendors and contract laboratories, supports audits, and trains junior analysts on laboratory procedures and quality standards.