Associate Quality Control - TIM Lab Analyst

Amgen•Thousand Oaks, CA

About The Position

Join Amgen's Mission of Serving Patients At 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. Associate Quality Control - TIM Lab Analyst What you will do Let's do this. Let's change the world. In this vital role you will be expected to primarily provide testing of HPLC and CE assays and to ensure quality and operational excellence within the HPLC/CE team at the Amgen Thousand Oaks Site. Responsibilities include performing sample testing and approval, performing supporting activities such as SOP/method revision, equipment validation, method transfers, and general troubleshooting. This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH. The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make relevant improvements in the QC space. Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of the following activities: Performing routine laboratory procedures Routine analytical testing Documenting, computing, compiling, interpreting, and entering data Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents. Must learn and follow safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

Requirements

cGMP Experience
Experience in Capillary electrophoresis
Experience using Empower CDS, LIMS and/or SmartLab
Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation
Experience and knowledge of Data Integrity Requirements of QC Systems
Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
Excellent problem-solving capabilities and attention to detail
Experience of collaboration within and across functional areas and outstanding customer service focus
Excellent written and verbal communication skills
High school/GED + 2 years quality control work experience OR Associate's + 6 months quality control work experience OR Bachelor's
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to organize work, handle multiple priorities and meet deadlines
Strong written and oral communication skills
Must be detail orientated
Must be flexible and adaptable to changing priorities and requirements
Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
Demonstrates understanding of when and how to appropriately escalate.
May identify, recommend and implement improvements related to routine job functions.
Must learn and align with safety guideline and cGMPs.

Responsibilities

Report, evaluate, trend and approve analytical data.
Troubleshoot, solve problems and communicate with team members.
Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
Complete protocols and perform assay transfer/validation and equipment qualification/verification.
Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
Responsible for CEMS on call pager.
May participate in lab investigations.
May provide technical guidance.
May train others.
May represent the department/organization on various teams
May interact with outside resources
Performing routine laboratory procedures
Routine analytical testing
Documenting, computing, compiling, interpreting, and entering data
Maintaining and operating specialized equipment
Initiating and / or implementing changes in controlled documents.
Must learn and follow safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

Benefits

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.
A 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
Flexible work models where possible.

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