Senior Associate Manufacturing – Manufacturing Investigations

Senior Associate Manufacturing –Manufacturing Investigations

Live

What youwill do

Let’sdo this.Let’schange the world. In this vital role, you will be a key member of the team that investigatesmajordeviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams andstakeholder groupsincluding,Process Development,Facilities &Engineering,Automation, EHSS, andQuality. This positionis responsible forensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include:

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.

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Win

What we expectofyou

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:

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience

Or​

Associate’s Degree + 2 years manufacturing and/or other regulated environment experience

Or​

Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience

Or

Master's ​Degree

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

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Thrive

What you can expectofus

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

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Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 areprovidedreasonable accommodation toparticipatein 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.

#AmgenNorthCarolina

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Salary Range

86,048.05USD -116,417.95 USD