Systems Ally · 2 days ago

Quality Engineer

North Chicago, IL

Full-time

Onsite

Senior Level

5+ years exp

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ConsultingLife Science

Hiring Manager

Gajendra Parmar

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Responsibilities

Performs and documents GMP root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for R&D clinical drug product manufacturing and packaging.

Driving the event investigation down to the root cause, suggest corrective actions, and document findings.

Develops, documents, and tracks to completion corrective and preventive actions (CAPA) to prevent nonconformities from occurring again.

Performs other compliance related tasks to support the business, such as authoring change requests to operating procedures, providing support for internal and customer audits and reviewing logbooks, batch records, etc. for accuracy and completeness.

Holds regular review meetings and monitors tasks to ensure timely completion.

Ensure that all investigations are written according to corporate, division, and local requirements.

Responsible for consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements.

Coordinate the exception document process and write exception documents.

Work as individual contributor mostly; expected to lead own investigation cases.

Working in GMP regulated production area performing exception reporting/investigation.

Qualification

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Technical writingCAPAQuality AssurancePharmaceutical ManufacturingRegulatory requirementsGxP environmentQualification/validationDocumentationCompliance21 CFR Part 11EU GMP Annex 11/15ICHPIC/SGAMP5CommunicationTeamworkGlobal environmentGMP ManufacturingQuality SettingsPharma ExperienceTrackwise Experience

Required

Extensive technical writing capability for nonconformances and investigations

Must have CAPA experience

4 year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology

Minimum of 5+ years of experience in Quality Assurance or Pharmaceutical Manufacturing such as regulated GxP environment in qualification / validation, documentation, operations, or compliance

Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.)

Excellent communication capabilities and teamwork capacities

Proven ability to work in a global environment and with in-person and virtual teams