Amgen
Sr Associate Mfg I- Investigations
US - North Carolina - Holly Springs · Senior
Sponsorship not specifiedDetected 8 hours ago
Project ManagementGMPResearchCommunicationCollaborationProblem SolvingCritical ThinkingWriting
About the role
- 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.
Responsibilities
- 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.
- 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.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
Requirements
- Bachelor's degree & 6 months of directly related work experience
- Associate's degree & 2 years of directly related work experience
- High school/GED & 4 years of directly related work experience
Nice to have
- 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
Compensation
- 86,048.05USD -116,417.95 USD
Benefits
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
Company info
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.