Senior Associate ManufacturingManufacturing Investigations

BioSpace; Holly Springs (NC); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Flexible work models

Stock-based long-term incentives

Job summary

Amgen is seeking a Senior Associate for Manufacturing Investigations at the FleXbatch site in North Carolina. You will manage environmental monitoring investigations, perform root cause analysis, and develop CAPAs to ensure product quality and compliance.

The role requires collaboration across cross-functional teams and effective communication with regulators and management. The position offers exposure to state-of-the-art manufacturing technologies, industry 4.0 capabilities, and a

Qualifications

• High School Diploma/GED with 4+ years in manufacturing or regulated environments
• Associate’s Degree with 2+ years in manufacturing or regulated environments
• Bachelor’s Degree with 6 months+ in manufacturing or regulated environments
• Master’s Degree in a related field
• Experience leading investigations
• Experience with Veeva QMS for Deviation investigations and CAPAs

Responsibilities

• Manage deviation and environmental monitoring investigations within the Controlled Environmental Monitoring space
• Lead root cause analysis and development of CAPAs
• Interpret environmental monitoring data and assess impact on product quality
• Present investigations to regulators and internal auditors
• Communicate investigation progress to impacted areas and leadership
• Coordinate cross-functional teams to complete milestones on schedule
• Prepare and present findings in clear, concise technical writing
• Develop tracking tools to ensure on-time closure of investigations

Skills

Investigations

Cross-functional collaboration

Communication skills

Problem solving

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

Veeva QMS

Job description

HOW MIGHT YOU DEFY IMAGINATION? If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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.

Senior Associate Manufacturing Manufacturing Investigations

Live

What you will do

• Managesimpledeviationand environmental monitoringinvestigations,specifically within theControlledEnvironmental 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,identifytrends, and assess potential impactstoproduct quality, manufacturing operations, and contamination control programs.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress toimpactedareas 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
• UseOperationalLearningTeam strategies topromote open collaboration with stafftomaximizeinvestigation findings.
• Developtracking tools to ensure on-time closure and proactivereviewof deviation investigations.
• Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas a biologics Drug Substancemanufacturingandmicrobiologicalinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications

• HighSchoolDiploma/GED + 4yearsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• AssociatesDegree+ 2 yearsmanufacturing and/orotherregulated environment experience
• Or
• BachelorsDegree+ 6 monthsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• Master'sDegree

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 complexroot cause analysistools (5-whys, fishboneetc.)critical thinking, project management, and quality systems.
• Degree in Science or Engineering(Microbiology or similar a plus)
• Experience leading investigations
• Experience usingVeevaQMSfor 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
• Thrive

What you can expect of us

In Addition To The Base Salary, Amgen Offers a Total Rewards Plancomprisinghealth 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 Including

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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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