Holly Springs, North Carolina, United States · On-site
$86k–$116k/yr
Career CategoryOperationsJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious …
Skills: Root Cause Analysis, CAPA Development, Technical Writing, Environmental Monitoring, Microbiology Principles
Charlotte, North Carolina, United States · On-site
$63/hr–$87/hr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Clinical Sales, Territory Planning, Patient Retention, HCP Engagement, Specialty Biologics
Hickory, North Carolina, United States · On-site
$122k–$167k/yr
Requisition Number: 76609 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Precision Machine Design, CAD (SolidWorks/Vault), Kinematic Design, Error Budgeting, Tolerance Analysis
Mooresville, North Carolina, United States · On-site
Corvid Technologies is looking to add an experienced Mechanical Engineer with a passion for precision drafting, Geometric Dimensioning and Tolerancing (GD&T), and Technical Data Package (TDP) creation. The engineer in th…
Skills: GD&T, Technical Data Package (TDP) Creation, SolidWorks, Creo, NX
Wake County, North Carolina, United States · On-site
$37k–$65k/yr
Agency Dept of Transportation Division State Hwy Administrator - Div of Hwys Job Classification Title Engineering Technician I (S) Position Number 60023746 Grade NC07 About Us It’s the mission of the NC Department of Tra…
Skills: Soil Testing, Aggregate Testing, Data Analysis, Laboratory Equipment Maintenance, AASHTO Standards
Durham, North Carolina, United States · On-site
$23/hr–$34/hr
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusi…
Skills: Oral Communication, Written Communication, Microsoft Excel, Microsoft Outlook, Data Entry
Charlotte, North Carolina, United States · On-site
$35/hr–$53/hr
Department: 02050 GCMG SHVI: Ballantyne - Cardiology Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Monday through Friday 8 am to 4:30 pm **This role does include opp…
Skills: Echocardiography, 2D Imaging, 3D Imaging, Doppler, Transesophageal Echocardiogram
Durham, North Carolina, United States · Hybrid
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination …
Skills: Motion Control, AC Power Electronics, Motors And Controls, Sensors, Servo Systems
Burlington, North Carolina, United States · On-site
Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improv…
Skills: Clinical Laboratory Testing, Team Leadership, Instrumentation Troubleshooting, Quality Control, Specimen Processing
Hickory, North Carolina, United States · On-site
$85k–$117k/yr
Requisition Number: 76604 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Mechanical Design, Precision Engineering, Tolerance Analysis, SolidWorks, Vault
Concord, North Carolina, United States · On-site
$65k–$169k/yr
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headqua…
Skills: Quality Assurance, Pharmaceutical Manufacturing, Commissioning and Qualification, Verification and Validation, Computer Systems Validation
Asheville, North Carolina, United States · On-site
$87k–$165k/yr
Date Posted: 2026-07-21 Country: United States of America Location: US-NC-ASHEVILLE-330 ~ 330 Pratt Whitney Blvd ~ PRATT WHITNEY Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U…
Skills: Mechanical Design, GD&T, Siemens NX, Teamcenter, ANSYS
Durham, North Carolina, United States · On-site
$93k–$233k/yr
Job Overview Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Project Lead is an essenti…
Skills: Clinical Trial Management, Project Delivery, Bid Defense, Strategic Planning, Risk Management
Bessemer City, North Carolina, United States · On-site
· Join a leading global company · Be part of a group that is safety driven and values inclusion · Our friendly teams look after each other because your safety and wellbeing are always our priority We’re Finding Better Wa…
Skills: Inductively Coupled Plasma, Gas Chromatography, Auto-titrators, Karl Fischer Titration, LQM Software
Claremont, North Carolina, United States · On-site
Prysmian is the world leader in the energy and telecom cable systems industry. Each year, the company manufacturers thousands of miles of underground and submarine cables and systems for power transmission and distributi…
Skills: Process Industrialization, Technology Transfer, Chemical Deposition, Process Optimization, Data Analysis
Charlotte, North Carolina, United States · On-site
About this role: Wells Fargo is seeking a highly technical and hands-on Senior Lead for Mortgage Data Analytics (Senior Lead Quantitative Model Solutions Specialist) to own and lead the Mortgage Model Development Center’…
Skills: Mortgage Data Analytics, Python, SQL, MBS/EMBS Analysis, Quantitative Modeling
Morrisville, North Carolina, United States · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior/Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Senior/Principal Country Appr…
Skills: Regulatory Submissions, Local Regulatory Strategy, Clinical Trial Startup, Project Coordination, Regulatory Compliance
Asheville, North Carolina, United States · On-site
$108k–$205k/yr
Date Posted: 2026-07-21 Country: United States of America Location: US-NC-ASHEVILLE-330 ~ 330 Pratt Whitney Blvd ~ PRATT WHITNEY Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U…
Skills: Manufacturing Engineering, Technical Project Management, Process Qualification, NPI Implementation, Six Sigma
Morrisville, North Carolina, United States · On-site
$62k–$77k/yr
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare dis…
Skills: cGMP Manufacturing, Aseptic Operations, Process Validation, SOP Creation, Batch Record Review
Wilson, North Carolina, United States · On-site
$117k–$184k/yr
Job Description Position Overview - Basic Functions & Responsibility Essential function{s) includes, but is not limited to: Reporting to the Associate Director of PTO Engineering, the Senior Specialist Engineer is respon…
Skills: Device Packaging, Good Manufacturing Practices (GMP), Lean Six Sigma (LSS), Oral Solid Dosage, Packaging Engineering
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The role involves investigating major deviations and environmental monitoring issues within a biologics drug substance manufacturing plant. Key duties include leading root cause analysis, developing CAPAs, and coordinating with cross-functional stakeholders to ensure compliant documentation.
Candidates need a degree in Science or Engineering with varying levels of experience depending on the degree held (from High School to Master's). Preferred qualifications include 3+ years of biotech/pharma experience and proficiency with Veeva QMS and root cause analysis tools.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Associate Manufacturing I – Investigations
Let’s do this. Let’s change the world. In this vital role you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including; Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Manage simple deviation and environmental monitoring investigations, specifically within the Controlled Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
Interpret environmental monitoring data, identify trends, and assess potential impacts to product quality, manufacturing operations, and contamination control programs.
Present investigations to regulatory inspectors, internal auditors, and management.
Clearly communicate investigation progress to impacted areas and leadership.
Coordinate and effectively lead cross-functional teams through investigations, and complete milestones on-schedule.
Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner. Build effective relationships across functions.
Navigate through ambiguity and provide a structured problem-solving approach.
Apply inductive and deductive reasoning in the investigation process
Clear and concise technical writing
Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Master’s degree
Or
Bachelor’s degree & 6 months of directly related work experience
Or
Associate’s degree & 2 years of directly related work experience
Or
High school/GED & 4 years of directly related work experience
Preferred Qualifications:
3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.
Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone etc.) critical thinking, project management, and quality systems.
Degree in Science or Engineering (Microbiology or similar a plus)
Experience leading investigations
Experience using Veeva QMS for Deviation investigations and CAPAs
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Strong interpersonal skills
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.#WeareBiotech
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
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