Quality Assurance Specialist - Batch records

About the role

Perform duties and responsibilities in support of the client’s Quality Assurance program under minimal supervision, focusing on batch record review and release.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Lead investigations, NC investigations, CAPA records, and change controls.
• Approve environmental characterization reports, sanitary utility system releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and lead site audits.
• Provide lot disposition, authorize shipments, and review work orders, EMS/BMS alarms.
• Support automation, facilities, environmental programs, and risk assessments.

Required profile

• Doctorate, or Master’s + 2 years, or Bachelor’s + 4 years, or Associate’s + 8 years, or High school/GED + 10 years of directly related experience.
• Strong project‑management and organizational abilities.
• Proven ability to interact with regulatory agencies and cross‑functional teams.

Required skills

• cGMP processes, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise.
• Deviations, CAPA, change control, validation (IQ, OQ, PQ) of GxP applications.
• Data trending, compliance evaluation, and advanced spreadsheet/database skills.
• Fluent written and oral communication in English (and Spanish).