On-Floor Quality Engineer - cGMP/Regulatory (3rd Shift)

Actalent; Scarborough (ME); Vor Ort; USD 51.000 - 55.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Zusammenfassung

Actalent is hiring a Manufacturing Line Quality Engineer for Scarborough, ME, in an Infectious Disease production environment. The role focuses on quality assurance, process improvement, and strict adherence to regulatory requirements on the manufacturing floor.

You will work with production teams to ensure accurate documentation, effective QMS implementation, and on-floor resolution of quality issues, with a 3rd shift schedule and contract employment.

Qualifikationen

• Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science, or another technical field, or an equivalent combination of education and experience.
• Knowledge of FDA cGMP, QSR, ISO quality systems.
• Strong technical writing and documentation skills.
• Clear verbal and written communication with production and quality teams.
• Understanding of GMP and cGMP in regulated environments.
• Ability to work on a manufacturing floor and resolve quality issues in real time.
• Awareness of device defects and quality risks in design, verification/validation, and manufacturing.

Aufgaben

• Support production teams in resolving quality issues per procedures and regulatory requirements.
• Provide on-the-floor support to manufacturing operations to ensure adherence to procedures.
• Ensure complete Device History Record (DHR) documentation for manufacturing activities.
• Support line clearances, reworks, and inspections to maintain quality and compliance.
• Drive development and effectiveness of the Quality Management System per ISO, FDA, and regulatory requirements.
• Maintain professional behavior reflecting on the organization and comply with policies.
• Understand quality consequences of tasks and prevent issues.
• Identify device defects related to design, verification/validation, manufacturing and testing.
• Collaborate with cross-functional teams to implement corrective and preventive actions.
• Perform other duties to support changing business needs.

Kenntnisse

cGMPs knowledge

QSR knowledge

ISO quality system

Technical writing

Verbal communication

GMP/cGMP understanding

On-floor problem solving

Ausbildung

Bachelor's degree in Engineering/Science

Jobbeschreibung

Actalent is hiring a Manufacturing Line Quality Engineer for Scarborough, ME, in an Infectious Disease production environment. The role focuses on quality assurance, process improvement, and strict adherence to regulatory requirements on the manufacturing floor.

You will work with production teams to ensure accurate documentation, effective QMS implementation, and on-floor resolution of quality issues, with a 3rd shift schedule and contract employment.