Sterility Assurance Consultant – Pharmaceutical (GMP, Data Integrity, CAPA, FDA Remediation)

Job Summary: Our client, a pharmaceutical sterile manufacturing operation in Greenville, North Carolina, is seeking a Senior Consultant to support sterility assurance and GMP quality activities. This role covers contamination control, aseptic process oversight, deviation and CAPA management, data integrity, and support of FDA remediation commitments. This is a hands‑on consulting role working closely with Manufacturing, Quality and Regulatory teams in a regulated sterile environment. ResponsibilitiesProvide sterility assurance oversight for aseptic manufacturing operations Support contamination control strategy, environmental monitoring programs and trend review Lead and support deviation investigations, OOS and OOT investigations and root cause analysis Author, review and drive CAPAs through to closure, including effectiveness checks Support FDA remediation commitments and ensure timely, defensible closure of observations Apply data integrity principles (ALCOA+) across records, systems and documentation practices Review batch records and support product disposition activities Support audit and regulatory inspection readiness, including preparation of evidence packages Review and approve SOPs, protocols and quality records for compliance Partner with Manufacturing, Quality, Validation and Regulatory teams on compliance initiatives

Qualifications: Bachelor's degree in Microbiology, Biology, Chemistry, Engineering or a related scientific discipline 3 5+ years of experience in pharmaceutical quality, sterility assurance or GMP compliance Experience in sterile or aseptic pharmaceutical manufacturing Strong working knowledge of cGMP, 21 CFR Parts 210 and 211, and data integrity (ALCOA+) Demonstrated experience with deviation investigations, CAPA and root cause analysis Experience supporting FDA inspections, observations or remediation activities

Preferred: environmental monitoring, media fills and aseptic process simulation, contamination control strategy, sterilization validation, 21 CFR Part 11 Strong technical writing and documentation skills Ability to work onsite in Greenville, North Carolina Minimum 3 years of professional post‑graduation experience required. This position is not suitable for recent graduates or current students Must be authorized to work in the United States without sponsorship, now or in the future W2 employment only