PQA Quality Assurance Lead - 1st Shift (Onsite)

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

Job summary

Amgen is seeking a Sr Associate Quality Assurance (PQA) for 1st shift to partner with Manufacturing and Quality to sustain cGMP compliance across bulk drug substance operations and new product introductions. The role emphasizes real-time decision-making, coaching across events, deviations, CAPA, and validation activities on 24/7 operations.

You will support commissioning/qualification activities and provide on-the-floor QA oversight, ensuring products are manufactured, tested, stored, and

Qualifications

• High school/GED with 4 years in quality, manufacturing or regulated environments.
• Associates degree with 2 years in quality, manufacturing or regulated environments.
• Bachelors degree with 6 months in quality, manufacturing or regulated environments.
• Master's degree preferred.

Responsibilities

• Provide real-time quality oversight to ensure adherence to cGMP and GDP requirements.
• Coach and guide manufacturing events, deviations, CAPA, change control and validations.
• Support commissioning, qualification and validation activities for ANC facility and equipment.
• Lead audits and inspections support; interact with regulatory agencies as needed.
• Communicate quality issues to senior management and drive timely resolutions.

Skills

cGMP + GDP practices

Biotech/pharma plant startup

cGMP manufacturing knowledge

Upstream/downstream biotech制造

Education

High school/GED + 4 years of Quality/mfg work

Associates + 2 years of Quality/mfg work

Bachelors + 6 months of Quality/mfg work

Master's degree

Tools

MS Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen is seeking a Sr Associate Quality Assurance (PQA) for 1st shift to partner with Manufacturing and Quality to sustain cGMP compliance across bulk drug substance operations and new product introductions. The role emphasizes real-time decision-making, coaching across events, deviations, CAPA, and validation activities on 24/7 operations.

You will support commissioning/qualification activities and provide on-the-floor QA oversight, ensuring products are manufactured, tested, stored, and