Sr Associate Quality Control

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in biotechnology is seeking a Sr Associate in Quality Control to ensure product quality and compliance. In this pivotal role, you will oversee analytical testing, manage quality processes, and collaborate with production teams to resolve quality issues. This opportunity offers a chance to make a significant impact on patient lives while advancing your career in a dynamic and innovative environment. Join a company that values collaboration and professional growth, and be part of a mission that truly matters.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Qualifications

• 4+ years of experience in Quality Control or operations in a GMP environment.
• Strong knowledge of laboratory testing methods and equipment.

Responsibilities

• Oversee quality of products and manufacturing processes in a GMP environment.
• Plan and perform analytical testing on raw materials and drug substances.

Skills

Quality Control

Analytical Testing

GMP Compliance

Troubleshooting

Laboratory Investigations

Education

High School Diploma or GED

Associate's Degree

Bachelor's Degree

Master's Degree

Tools

Immunosorbent Assay

Chromatography (HPLC, UPLC, LC-MS)

Capillary Electrophoresis

FT-IR

Job description

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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate Quality Control

What you will do

Let's do this. Let's change the world. In this vital role, you will be responsible for overseeing the quality of products and manufacturing processes. You will manage QC testing, analyze data, document results, and work closely with the production team to correct any quality issues, all while ensuring compliance with regulatory standards.

Responsibilities:

• Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance, and stability samples in a GMP pharmaceutical environment.
• Troubleshoot issues related to analytical testing, techniques, and equipment.
• Conduct laboratory investigations and assist in timely closure of investigations, CAPAs, and deviations.
• Support method verification and method validation/transfer for new product introduction (when required).
• Train new/junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job.
• Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping, and document archival duties.
• Perform periodic review of laboratory procedures and risk assessment.
• Author SOPs/protocols/reports.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go-getter with these qualifications.

Basic Qualifications:

• High school/GED + 4 years of Quality and/or operations experience OR
• Associates + 2 years of Quality and/or operations experience OR
• Bachelors + 6 months of Quality and/or operations experience OR
• Master's.

Preferred Qualifications:

• High school diploma/GED and 8 years of quality experience.
• Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred.
• Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation, and associated testing methods.
• Strong technical knowledge in and experience with the following QC Chemistry/Biochemistry/Raw material testing methods and equipment is required:
• Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA.
• Chromatography: UPLC, HPLC, LC-MS, GC-HS.
• General Chemistry: Capillary Electrophoresis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry.
• Ability to preempt issues and disruptions to lab operations and develop mitigation actions.

What 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.

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, based on eligibility, comprising health 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 that may include:

• 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, including remote and hybrid work arrangements, where possible.

Apply now

for a career that defies imagination

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

careers.amgen.com

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.

Application deadline

Amgen anticipates accepting applications until 2/11/25; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

As 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.