You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.
You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.
Win What we expect of you The collaborative investigator weseekhas extensive experience leading ... Strong understanding of GMP regulations, quality systems, deviation management, CAPA systems, and ...
Win What we expect of you The collaborative investigator weseekhas extensive experience leading ... Strong understanding of GMP regulations, quality systems, deviation management, CAPA systems, and ...
Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events ...
Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events ...
Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events ...
Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events ...
Documentation Specialist
Durham, NC ยท On-site
$29.50/hr
... deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams ...
Documentation Specialist
Durham, NC ยท On-site
$29.50/hr
... deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams ...
Deviation Management Specialist
Durham, NC ยท On-site
$72K - $83K/yr
Technical Operations & Quality Investigations Specialist Role Overview We are seeking a Technical Operations & Quality Investigations Specialist to provide direct technical support to our ...
Deviation Management Specialist
Durham, NC ยท On-site
$72K - $83K/yr
Technical Operations & Quality Investigations Specialist Role Overview We are seeking a Technical Operations & Quality Investigations Specialist to provide direct technical support to our ...
Manufacturing Engineer
$71K - $91K/yr
Manages and tracks completion timelines for compliance tasks (change controls, deviation investigations, corrective & preventive actions) Supports creation of new procedures for equipment and systems ...
Manufacturing Engineer
$71K - $91K/yr
Manages and tracks completion timelines for compliance tasks (change controls, deviation investigations, corrective & preventive actions) Supports creation of new procedures for equipment and systems ...
... Deviation investigation and technical assessments Collection, organization, trending, and analysis of GMP manufacturing data The candidate should be able to work independently and in a ...
... Deviation investigation and technical assessments Collection, organization, trending, and analysis of GMP manufacturing data The candidate should be able to work independently and in a ...
Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.
Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables. * Assist with deviation investigations, change control processes, and documentation ...
Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables. * Assist with deviation investigations, change control processes, and documentation ...
Senior QA Specialist Deviations and CAPAs
Durham, NC ยท On-site
$79K - $109K/yr
Mentors junior QA staff in deviation/CAPA review and approval to include training and certification ... Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs.
Senior QA Specialist Deviations and CAPAs
Durham, NC ยท On-site
$79K - $109K/yr
Mentors junior QA staff in deviation/CAPA review and approval to include training and certification ... Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs.
Senior QA Specialist Deviations and CAPAs
Durham, NC ยท On-site
$79K - $109K/yr
Mentors junior QA staff in deviation/CAPA review and approval to include training and certification ... Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs.
Senior QA Specialist Deviations and CAPAs
Durham, NC ยท On-site
$79K - $109K/yr
Mentors junior QA staff in deviation/CAPA review and approval to include training and certification ... Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs.
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Manufacturing QUALITY MANAGER - Packaging
Raleigh, NC ยท On-site
$115K - $125K/yr
... deviation investigations (RCA) conducted at site level for both internal and external deviations including the systematic capturing and implementation of Corrective and Preventive Actions. Supplier ...
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Be Seen First
Manufacturing QUALITY MANAGER - Packaging
Raleigh, NC ยท On-site
$115K - $125K/yr
... deviation investigations (RCA) conducted at site level for both internal and external deviations including the systematic capturing and implementation of Corrective and Preventive Actions. Supplier ...
Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA * Strong written and verbal communication skills * Good organizational skills and attention to ...
Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA * Strong written and verbal communication skills * Good organizational skills and attention to ...
QA Operations Head (Associate Director)
Durham, NC ยท On-site
$138K - $257K/yr
Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives. Desirable Requirements * Previous involvement ...
QA Operations Head (Associate Director)
Durham, NC ยท On-site
$138K - $257K/yr
Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives. Desirable Requirements * Previous involvement ...
Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation ...
Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation ...
QA Operations Head (Associate Director)
$138K - $257K/yr
Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives. Desirable Requirements * Previous involvement ...
QA Operations Head (Associate Director)
$138K - $257K/yr
Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives. Desirable Requirements * Previous involvement ...
Deviation Investigator information
See Raleigh, NC salary details
$31.1K - $39.9K
7% of jobs
$39.9K - $48.6K
14% of jobs
$50K is the 25th percentile. Wages below this are outliers.
$48.6K - $57.3K
24% of jobs
The median wage is $61.7K / yr.
$57.3K - $66.1K
9% of jobs
$66.1K - $74.8K
5% of jobs
$74.8K - $83.6K
15% of jobs
$84.3K is the 75th percentile. Wages above this are outliers.
$83.6K - $92.3K
3% of jobs
$92.3K - $101.1K
6% of jobs
$101.1K - $109.8K
4% of jobs
$109.8K - $118.6K
12% of jobs
$118.6K - $127.3K
0% of jobs
$31.1K
$73.2K
$127.3K
How much do deviation investigator jobs pay per year?
What does a deviation investigator do?
A typical day for a Deviation Investigator involves reviewing deviation reports, gathering data from production or laboratory records, and conducting interviews with staff to determine the root cause of incidents. You will document findings in compliance with standard operating procedures and collaborate closely with cross-functional teams, such as manufacturing, quality assurance, and regulatory affairs, to recommend corrective and preventive actions. Many Deviation Investigators participate in regular meetings to discuss ongoing cases and share best practices. The role requires excellent organizational skills to manage multiple investigations concurrently while ensuring timely and thorough resolution.
What is a deviation investigator?
A Deviation Investigator is responsible for analyzing deviations in manufacturing, quality control, or laboratory processes within industries like pharmaceuticals or biotechnology. They identify root causes, document findings, and implement corrective and preventive actions (CAPAs) to ensure compliance with regulatory standards. Their role is crucial in maintaining product quality, safety, and adherence to Good Manufacturing Practices (GMP). Effective communication, problem-solving skills, and knowledge of industry regulations are essential for this position.
What are the key skills and qualifications needed to thrive as a deviation investigator?
To thrive as a Deviation Investigator, you need a strong background in quality assurance or compliance, along with experience in root cause analysis and deviation management, often supported by a degree in a scientific or technical field. Familiarity with industry regulations (such as GMP or ISO standards), quality management systems (QMS), and tools like TrackWise or MasterControl is highly desirable. Strong analytical thinking, attention to detail, effective communication, and the ability to work collaboratively are key soft skills for this role. These skills ensure accurate investigation, thorough documentation, and prompt resolution of deviations to maintain product quality and regulatory compliance.

Full-time
Medical, Retirement, PTO
Posted 25 days ago
Job description
Manufacturing
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Manager Manufacturing Programs -Investigations
Live
What you will do
Let's do this. Let's change the world. In this vital leadership role, you will lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.
- Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
- Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
- Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem-solving discussions.
- Manage team priorities, workload balancing, resource planning, and performance management.
- Provide technical oversight of manufacturing and environmental monitoring investigations.
- Drive consistency in root cause analysis and CAPA development.
- Serve as site subject matter expert for Environmental Monitoring related investigations.
- Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
- Lead escalation and governance for deviations.
- Support and present during regulatory inspections and internal audits.
- Monitor investigation metrics and drive continuous improvement.
- Champion Operational Learning Team principles and organizational learning.
- Develop investigation procedures, standards, and training.
- Build a culture of accountability, inclusion, and operational excellence.
Win
What we expect of you
The collaborative leader we seek has extensive biologics drug substance manufacturing experience with demonstrated success leading technical teams, driving cross-functional collaboration, and improving quality systems.
Basic Qualifications
- Doctorate degree
- Master's degree and 3 years of directly related experience
- OR Bachelor's degree and 5 years of directly related experience
- OR Associate's degree and 10 years of directly related experience
- OR High school diploma/GED and 12 years of directly related experience
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications
- 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience.
- 0-2 years of people leadership or technical leadership.
- Strong knowledge of GMPs, contamination control, and environmental monitoring.
- Expertise leading investigations and root cause analysis.
- Degree in Science or Engineering (Microbiology or similar a plus).
- Experience with Veeva QMS or equivalent quality systems.
- Experience supporting FDA and global regulatory inspections.
- Strong communication, coaching, and organizational leadership skills.
Thrive
The annual salary range for this opportunity in the U.S. is [HR to input market pay range].
In addition to base salary, Amgen offers a comprehensive Total Rewards package including health and welfare benefits, retirement savings, annual bonus opportunity, stock-based long-term incentives, generous paid time off, company shutdowns, and career development opportunities.
Salary Range
USD - USD