Sr. Associate Qc

Join Amgen's Mission of Serving PatientsAt 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.
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 QC What you will doLet's do this.
Let's change the world.
In this vital role you will under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance.
This role is for an experienced and technically strong associate who will spend 90% of their workday performing testing.
Endotoxin testing of water, in-process and drug product release samplesBioburden testing of water & in-process drug product samplesSterility testingWater samplingLab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.Writing technical reportsMedia fill reconciliation and inspectionWeekend bio burden coverPerform analytical testing as a main priority with efficiency and accuracyWith a high degree of technical flexibility, work across diverse areas within the labPlan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.Report, evaluate, archive, trend and approve analytical data.Troubleshoot, solve problems and communicate with stakeholders.Initiate and/or implement changes in controlled documents.Participate in audits, initiatives, and projects that may be departmental or organizational in scope.Write protocols and perform assay validation.Introduce new techniques to the lab, including method transfers, reports, validations and protocols.Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.Review and Approve lab resultsMay participate in lab investigations.May provide technical guidance.May train others.May contribute to regulatory filings.May represent the department/organization on various teamsMay interact with outside resources Responsibility 1What we expect of youWe are all different, yet we all use our unique contributions to serve patients.
The QC professional we seek is a collaborative individual with these qualifications.
Basic Qualifications: Bachelors degree in a science disciplineBiopharmaceutical QC experience in a microbiology labExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical productsPreferred Qualifications: Experience working in endotoxin, bioburden or sterility testingProficient in GMP systems such as LIMS Labware & LMESExperience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories.
Deepens technical knowledge through exposure and continuous learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery SkillsTake initiative to identify and drive improvementsExcellent verbal and written communication skillsStrong Technical writing skills for GMP documentation (e.g.
investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision Making skillsTeamwork and Coaching othersNegotiation and Influence skillsProblem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environmentDevelops solutions to technical problems of moderate complexityScreens, categorizes, evaluates, reconciles, reports, and resolves data integrity issuesInterprets generally defined practices and methodsWhat 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs 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.

#J-18808-Ljbffr