Quality Specialist I: GMP Compliance & Documentation

AptarGroup, Inc.; Gibsonia (Allegheny County); Sur place; USD 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

401k with company match

Paid time off

Medical, dental, vision

Résumé du poste

Aptar Pharma in Gibsonia, PA is seeking a Quality Specialist I to provide administrative and operational support for the Quality Management System (QMS). You will assist with document control, audits, records management and GMP-regulated compliance to ensure efficiency and adherence to procedures.

Responsibilities include coordinating audits, converting records to electronic formats, maintaining training records, authoring SOPs and supporting CAPAs, deviations, and GDP-compliant project

Qualifications

• Four-year degree or equivalent experience in Life Sciences or related field.
• Minimum 1–2 years of experience, preferably in Quality, manufacturing/laboratory, or regulated industry (e.g., pharmaceutical, ISO).
• Experience with data integrity concepts and ALCOA principles is preferred.

Responsabilités

• Audit support: schedule inspections, prepare docs, provide on-site support.
• Record control: convert to electronic formats and manage records in systems.
• Document control: administer electronic document management and review workflows.
• Quality systems: assist with SOPs, CAPAs, deviations, and related records.
• Data management: generate monthly quality and compliance metrics.
• Project quality review: verify documentation for GDP and customer requirements.
• Logbook & notebook control: archive controlled logs and notebooks.
• Equipment management: coordinate calibrations, maintenance, and vendor actions.
• Asset & material management: receive and enter laboratory consumables.

Connaissances

Strong communication

Attention to detail

Fast learner

Interpersonal skills

Quality systems awareness

Formation

Four-year degree or equivalent in Life Sciences

Description du poste

Aptar Pharma in Gibsonia, PA is seeking a Quality Specialist I to provide administrative and operational support for the Quality Management System (QMS). You will assist with document control, audits, records management and GMP-regulated compliance to ensure efficiency and adherence to procedures.

Responsibilities include coordinating audits, converting records to electronic formats, maintaining training records, authoring SOPs and supporting CAPAs, deviations, and GDP-compliant project