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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 …
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Asheville, North Carolina, United States · On-site
$87k–$165k/yr
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Charlotte, North Carolina, United States · On-site
$90k–$110k/yr
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Rocky Mount, North Carolina, United States · On-site
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Charlotte, North Carolina, United States · On-site
Entry level
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Be a part of our mission! As a world leader in creating comfortable, sustainable, and efficient climate solutions for buildings, homes and transportation, it's our responsibility to put the planet first. For us at Trane …
Charlotte, North Carolina, United States · On-site
Entry level
Since 1869, we've connected people through food they love. We’re proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell’s brand, as well as Cape Cod, Chunky, Goldfish, Kettle…
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$86k–$116k/yr
Full-time
high school, associate degree, bachelor degree, postgraduate degree
Retirement And Savings Plan, Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Disability Insurance
Posted 15d ago
~40 hrs/week
Responsibilities
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.
Requirements
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.
Full job description
Career Category
Operations
Job Description
Join 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 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
What you will do
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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic 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
What you can expect of us
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:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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.
Application deadline
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
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.
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Salary Range
86,048.05USD -116,417.95 USD
Related keywords
BiologicsDrug SubstanceGMPVeeva QMSCAPARoot Cause Analysis5-WhysFishboneMicrobiologyEnvironmental MonitoringContamination ControlBiotechPharmaceuticalQuality AssuranceProcess DevelopmentCompliance
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
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
How much do Manufacturing jobs in North Carolina pay?
Based on 1482 listings with disclosed salaries, most manufacturing jobs in North Carolina pay between $69k–$166k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in North Carolina right now?
There are currently 8,467 open manufacturing positions in North Carolina listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in North Carolina?
Companies currently hiring include Corning Incorporated, Eaton, Butterball, ABB, Carrier, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in North Carolina?
Yes — 734 of the 8467 open manufacturing positions offer remote or hybrid work (187 remote, 547 hybrid).
How do I apply for Manufacturing jobs in North Carolina?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.