Job Summary
We are seeking a highly skilled Senior Quality Control Specialist to join our team. In this role, you will be responsible for performing microbiological testing, method transfers, sample and data management, and equipment maintenance in a fast-paced laboratory environment.
Key Responsibilities
* Perform endotoxin testing of water, in-process, and drug product release samples.
* Conduct bioburden testing of water and in-process drug product samples.
* Sterility testing.
* Water sampling.
* Lab support duties such as biological indicator testing, growth promotion, media preparation, identification, and autoclave.
* Writing technical reports.
* Media fill reconciliation and inspection.
* Weekend bio burden cover.
* Perform analytical testing with efficiency and accuracy.
* Work across diverse areas within the lab with a high degree of technical flexibility.
* Plan and perform multiple routine and 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 results.
* May participate in lab investigations.
* May provide technical guidance.
* May train others.
* May contribute to regulatory filings.
* May represent the department/organization on various teams.
Requirements
To be successful in this role, you will need:
* Bachelor's degree in a science discipline.
* Biopharmaceutical QC experience in a microbiology lab.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Preferred Qualifications
It would be beneficial if you have:
* Experience working in endotoxin, bioburden, or sterility testing.
* Proficient in GMP systems such as LIMS Labware & LMES.
* Experience 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.
What We Offer
We offer a competitive salary and comprehensive benefits package, including:
* A competitive base salary.
* A range of health insurance options.
* A 401(k) plan with company match.
* Generous paid time off.
* Professional development opportunities.
About Us
We are a global biotechnology company dedicated to improving the quality of life for people around the world. Our mission is to serve patients living with serious illnesses by developing innovative medicines that transform lives.
We foster 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.