Senior QA Specialist – 2nd Shift (GMP/Quality)

Regulatory Jobs; Holly Springs (NC); Presencial; USD 82.000 - 111.000; Jornada completa

Descripción de la vacante

Amgen in North Carolina seeks a Sr Associate Quality Assurance I – PQA for 2nd shift. You will collaborate with plant manufacturing and support groups on bulk drug substance manufacturing, driving real-time decisions to ensure GMP compliance.

The role includes on-site staffing for the PQA team, with a shift structure that may include weekends and transition to second shift hours. Strong cGMP and GDP experience plus regulatory familiarity are essential.

Formación

• High school/GED with 4+ years in quality/manufacturing/regulatory environment.
• Associate degree with 2+ years in quality/manufacturing/regulatory environment.
• Bachelor’s with 6 months in quality/manufacturing/regulatory environment or Master’s.

Responsabilidades

• Support ANC facility commissioning and qualification and manufacturing Analytical Equipment Qualification and Validation activities.
• Quality oversight of new product introduction covering facilities, utilities, equipment, systems and processes with alignment to Amgen Quality Systems.
• Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP and GDP.
• Ensure facilities, equipment, materials, processes comply with applicable regulations and Amgen requirements.
• Drive closure of cGMP processes, documents and records including deviations, CAPA, change controls.
• Ensure production/testing records are complete and compliant.
• Oversee and provide guidance during on-the-floor analytical testing.
• Alert management to quality, compliance, supply and safety risks.
• Provide project management support and drive timely task completion.
• Identify and implement continuous improvement opportunities within processes.
• Support and represent PQA during audits/inspections; may interact with regulatory agencies.

Conocimientos

cGMP/GDP knowledge

Biotech startup experience

Upstream/downstream manufacturing

Strong organizational skills

Strong communication

Team collaboration

Educación

High school/GED + 4+ years quality/manufacturing

Associate degree + 2+ years quality/manufacturing

Bachelor’s + 6 months quality/manufacturing

Master’s

Herramientas

Microsoft Office

EBR/MES

DeltaV

Electronic Quality Systems

Descripción del empleo

Amgen in North Carolina seeks a Sr Associate Quality Assurance I – PQA for 2nd shift. You will collaborate with plant manufacturing and support groups on bulk drug substance manufacturing, driving real-time decisions to ensure GMP compliance.

The role includes on-site staffing for the PQA team, with a shift structure that may include weekends and transition to second shift hours. Strong cGMP and GDP experience plus regulatory familiarity are essential.