Senior QA Associate - 2nd Shift, GMP Compliance

Amgen Inc.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen Inc. in the United States seeks a SR Associate Quality Assurance I for PQA on the 2nd shift to collaborate with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introductions.

The role focuses on real-time decision making to ensure GMP quality compliance and strong partnerships between Manufacturing and Quality staff. The incumbent will transition to a shift schedule (including weekends) and support deviation investigations, CAPA, and

Qualifications

• High school/GED with 4 years in quality, manufacturing and/or other regulated environment work experience
• Associate’s with 2 years of related experience
• Bachelor’s with 6 months of related experience
• Master's degree in a related field

Responsibilities

• Support ANC facility commissioning and qualification and manufacturing Equipment Qualification and Validation activities, perform quality review and approval of documents according to project timelines
• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
• Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), GDP and other applicable regulations
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to GMP, GDP, Safety, and other controls
• Drive closure/completion of cGMP processes, procedures, documents and records, including deviations, investigations, CAPA, change control and validations
• Ensure production and testing records/results are complete and documented according to procedures, GDP and cGMP requirements
• Oversee and provide guidance during on-the-floor analytical testing
• Ensure that changes that could impact product quality are assessed according to procedures
• Ensure deviations from procedures are investigated and documented
• Alert senior management of quality, compliance, supply and safety risks
• Provide project management support and strategies for system implementation
• Identify and implement continuous improvement opportunities within our processes and systems
• Support and represent PQA during audits and inspections; may interact with regulatory agencies during on-site inspections

Skills

Quality

Manufacturing

cGMP

GDP

Education

High school/GED

Associate's

Bachelor's

Master's

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen Inc. in the United States seeks a SR Associate Quality Assurance I for PQA on the 2nd shift to collaborate with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introductions.

The role focuses on real-time decision making to ensure GMP quality compliance and strong partnerships between Manufacturing and Quality staff. The incumbent will transition to a shift schedule (including weekends) and support deviation investigations, CAPA, and