Associate Quality Control - TIM Lab Analyst

BioSpace; Thousand Oaks (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health and welfare plans

Retirement and Savings Plan

Flexible work models

Job summary

A leading biotechnology company in Thousand Oaks is seeking an Associate Quality Control - TIM Lab Analyst. This role involves testing HPLC and CE assays, ensuring operational excellence, and involvement in various quality control responsibilities. Candidates should have a background in quality control, experience with cGMP and analytical testing methods, as well as strong communication skills. The position offers a dynamic work environment focusing on patient-centered solutions and includes a comprehensive benefits package.

Qualifications

• High school diploma or GED with at least 2 years of quality control work experience.
• Associate's degree with 6 months of quality control work experience.
• Bachelor's degree also acceptable.

Responsibilities

• Report and approve analytical data.
• Troubleshoot and solve problems.
• Document data using electronic systems.
• Participate in departmental audits and initiatives.
• Evaluate lab practices for compliance.

Skills

cGMP Experience

Experience in Capillary electrophoresis

Experience using Empower CDS, LIMS and/or SmartLab

Proficient in Microsoft Office

Excellent problem‑solving capabilities

Attention to detail

Strong written and oral communication skills

Education

High school/GED + 2 years quality control work experience

Associate's degree + 6 months quality control work experience

Bachelor's degree

Tools

Waters H-Class UHPLC

Agilent HPLC instrumentation

Job description

Associate Quality Control - TIM Lab Analyst

Join Amgen's mission of serving patients living with serious illnesses. Since 1980, Amgen has pioneered biotech to fight the world’s toughest diseases. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives by researching, manufacturing, and delivering innovative medicines.

What You Will Do

In this vital role you will primarily provide testing of HPLC and CE assays and 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.

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.
• 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.

Additional duties

• 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 including maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

What We Expect Of You

Basic Qualifications

• High school/GED + 2 years quality control work experience OR
• Associate's degree + 6 months quality control work experience OR
• Bachelor's degree.

Preferred Qualifications

• 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 oriented.
• 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.

What You Can Expect Of Us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a total rewards plan, including health and welfare plans, financial plans, work/life balance, and career development opportunities. A comprehensive employee benefits package, including a Retirement and Savings Plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible.

Apply now and make a lasting impact with the Amgen team.

Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship: Sponsorship for this role is not guaranteed.

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.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.