Night Shift Plant QA: On-the-Floor Quality Lead

Amgen Inc.; West Greenwich (RI); Vor Ort; USD 82.000 - 111.000; Vollzeit

Benefits dieser Stelle

Stock-based long-term incentives

Discretionary annual bonus

Retirement and savings plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible work models

Zusammenfassung

Amgen seeks a Sr Associate QA- Nights to provide on-the-floor quality oversight during manufacturing operations, ensuring cGMP compliance and timely decisions with Manufacturing, Quality Control, and Facilities/Engineering teams.

The role includes reviewing SOPs, batch records, deviations, risk assessments, and training, while driving process improvements. The 12-hour night shift (7PM–7AM) rotates with weekend adjustments and a 15% shift differential.

Qualifikationen

• High school/GED plus 4 years QA or manufacturing experience.
• Associate’s + 2 years QA or manufacturing experience.
• Bachelor’s + 6 months QA or manufacturing experience.
• Master’s degree.
• Experience in a cGMP environment (preferred).
• Proficient in Microsoft Office.

Aufgaben

• Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
• Provide Quality oversight during on-the-floor analytical testing.
• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
• Alert senior management of potential quality, compliance, supply, or safety risks.
• Complete assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs, and projects.
• Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals

Kenntnisse

Quality assurance

Manufacturing

Analytical testing

Data integrity

MS Office

Ausbildung

High school/GED + 4 years QA or manufacturing experience

Associate’s + 2 years QA or manufacturing experience

Bachelor’s + 6 months QA or manufacturing experience

Master’s

Tools

Microsoft Office

Jobbeschreibung

Amgen seeks a Sr Associate QA- Nights to provide on-the-floor quality oversight during manufacturing operations, ensuring cGMP compliance and timely decisions with Manufacturing, Quality Control, and Facilities/Engineering teams.

The role includes reviewing SOPs, batch records, deviations, risk assessments, and training, while driving process improvements. The 12-hour night shift (7PM–7AM) rotates with weekend adjustments and a 15% shift differential.