Senior PQA - Night Shift, On-Site Quality Assurance

Amgen Inc.; Holly Springs (NC); On-site; USD 82,000 - 111,000; Full time

Job summary

Amgen Inc. in North Carolina is seeking a Sr Associate Quality Assurance (PQA) to join the on-the-floor team on the night shift.

You will collaborate with manufacturing and support groups to ensure products meet cGMP and GDP standards and to drive real-time quality decisions during new product introductions. You will oversee quality systems, CAPAs, deviations, change controls, and documentation, mentor staff, and participate in audits.

Qualifications

• High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR
• Associate’s + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience work experience OR
• Bachelor’s + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience work experience OR
• Master's

Responsibilities

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems.
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventive actions (CAPA), change control records and validations.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Skills

cGMP

GDP

Communication

Teamwork

Organizational skills

MS Office

Education

High school/GED

Associate's degree

Bachelor's degree

Master's degree

Tools

DeltaV

EBR/MES

Job description

Amgen Inc. in North Carolina is seeking a Sr Associate Quality Assurance (PQA) to join the on-the-floor team on the night shift.

You will collaborate with manufacturing and support groups to ensure products meet cGMP and GDP standards and to drive real-time quality decisions during new product introductions. You will oversee quality systems, CAPAs, deviations, change controls, and documentation, mentor staff, and participate in audits.