Manager, QA Evening 12 hour Shift (6:00pm-6:00am)
Amgen
8 hours ago
On-site
New Albany, OH
Operations
Manager, Plant Quality (Quality Assurance)
Responsibilities:
- Lead, coach, and develop Quality staff across assigned areas and shifts
- Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
- Ensure facilities, equipment, processes, materials, and products meet applicable quality and compliance standards
- Review, approve, and oversee key quality systems including: deviations; CAPAs; change controls; validation documentation; procedures and batch records
- Drive investigations and resolve deviations with timely, thorough, and compliant outcomes
- Ensure production records and test results are accurate, complete, and inspection-ready
- Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
- Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
- Assess and manage quality risks; escalate critical issues to senior leadership as needed
- Represent QA during internal/external audits and regulatory inspections; support audit readiness and inspection management
- Ensure document control excellence, including ownership and timely periodic review of controlled documents
- Foster a culture of quality, accountability, and compliance across all teams
Basic Qualifications:
- Doctorate degree
OR
- Master’s degree and 3 years of quality experience
OR
- Bachelor’s degree and 5 years of quality experience
OR
- Associate’s degree and 10 years of quality experience
OR
- High school diploma/GED and 12 years of quality experience
- Experience directly managing people and/or leadership experience leading teams, projects, or directing allocation/resources (may run concurrently with technical experience)
Preferred Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree a plus)
- 3+ years in Quality Assurance within a GMP-regulated environment (biotech/pharma preferred)
- Prior leadership/people management experience strongly preferred
- Deep knowledge of cGMP, GDP, and regulatory expectations
- Proven quality systems experience (deviations, CAPA, change control, validation)
- Ability to lead in a shift-based operation with flexibility for evenings, nights, weekends, or holidays
- Excellent communication, decision-making, and problem-solving skills
- Proactive, collaborative leader who can influence and inspire across functions
Benefits (explicitly stated):
- Total Rewards Plan (based on eligibility): health and welfare plans, financial plans (retirement savings opportunities), work/life balance, and career development opportunities
- Retirement and Savings Plan (generous company contributions); medical/dental/vision; life and disability insurance; flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales); stock-based long-term incentives; time-off plans; flexible work models where possible
Application Instructions:
- Apply now at careers.amgen.com
Responsibilities:
- Lead, coach, and develop Quality staff across assigned areas and shifts
- Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
- Ensure facilities, equipment, processes, materials, and products meet applicable quality and compliance standards
- Review, approve, and oversee key quality systems including: deviations; CAPAs; change controls; validation documentation; procedures and batch records
- Drive investigations and resolve deviations with timely, thorough, and compliant outcomes
- Ensure production records and test results are accurate, complete, and inspection-ready
- Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
- Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
- Assess and manage quality risks; escalate critical issues to senior leadership as needed
- Represent QA during internal/external audits and regulatory inspections; support audit readiness and inspection management
- Ensure document control excellence, including ownership and timely periodic review of controlled documents
- Foster a culture of quality, accountability, and compliance across all teams
Basic Qualifications:
- Doctorate degree
OR
- Master’s degree and 3 years of quality experience
OR
- Bachelor’s degree and 5 years of quality experience
OR
- Associate’s degree and 10 years of quality experience
OR
- High school diploma/GED and 12 years of quality experience
- Experience directly managing people and/or leadership experience leading teams, projects, or directing allocation/resources (may run concurrently with technical experience)
Preferred Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree a plus)
- 3+ years in Quality Assurance within a GMP-regulated environment (biotech/pharma preferred)
- Prior leadership/people management experience strongly preferred
- Deep knowledge of cGMP, GDP, and regulatory expectations
- Proven quality systems experience (deviations, CAPA, change control, validation)
- Ability to lead in a shift-based operation with flexibility for evenings, nights, weekends, or holidays
- Excellent communication, decision-making, and problem-solving skills
- Proactive, collaborative leader who can influence and inspire across functions
Benefits (explicitly stated):
- Total Rewards Plan (based on eligibility): health and welfare plans, financial plans (retirement savings opportunities), work/life balance, and career development opportunities
- Retirement and Savings Plan (generous company contributions); medical/dental/vision; life and disability insurance; flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales); stock-based long-term incentives; time-off plans; flexible work models where possible
Application Instructions:
- Apply now at careers.amgen.com