Senior Quality Control Analyst / Biologics

Kelly Services; Emeryville (CA); In loco; USD 51.000 - 59.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Transit spending account

Paid holidays

Descrizione del lavoro

Kelly Science & Clinical is seeking a Senior Quality Control Analyst in Emeryville, CA for a 4‑6 month contract. The role focuses on GMP testing of materials and products using HPLC/UPLC and ELISA, ensuring cGMP compliance and continuous process improvements.

You will support method development, validation, investigations, and audits while mentoring junior analysts and maintaining meticulous GMP records throughout the testing lifecycle.

Competenze

• Bachelor’s degree in a scientific discipline with 3–5 years GMP/QC experience or Master’s with 1–3 years.
• Hands‑on experience in a GMP‑regulated QC chemistry or analytical laboratory.
• Working knowledge of cGMP, data integrity, ICH and USP guidance.

Mansioni

• Perform GMP in‑process, release, and stability testing using HPLC/UPLC, residual ELISA, and other qualified methods.
• Maintain complete GMP records and follow SOPs and approved protocols.
• Troubleshoot assays and instrument issues; support laboratory investigations.
• Contribute to analytical development and IND‑enabling programs.
• Assist in method development, qualification, validation, and transfer per ICH guidance.
• Document deviations and contribute to CAPA investigations.
• Review GMP data packages for accuracy and compliance.
• Prepare reagents and reference standards and ensure laboratory readiness.
• Train and mentor junior QC analysts; support regulatory inspections.

Conoscenze

GMP/QC experience

Analytical testing

Laboratory troubleshooting

Mentoring junior staff

Formazione

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Strumenti

HPLC/UPLC

ELISA

Analytical instruments maintenance

Descrizione del lavoro

Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6-month contract opportunity with one of our clients, a leading biologics CDMO in Emeryville, CA. If you are driven by the prospect of translating cutting‑edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace: Emeryville, CA.

Position Title: Senior Quality Control Analyst

Position Type: 4-6-month Contract

Pay rate: $37-43 hour

Transform the Future of Biomanufacturing

A biopharmaceutical contract development and manufacturing organization (CDMO) is seeking a hands‑on Senior QC Analyst to support analytical testing across raw materials, in‑process samples, product release, and stability programs.

This role is a strong fit for an experienced GMP analyst who enjoys solving technical problems, strengthening analytical methods, and helping a collaborative QC team deliver reliable, inspection‑ready results. You’ll work across QC and partner functions, contribute to programs from early development through commercial readiness, and provide technical guidance to junior analysts.

What you’ll do

• Perform GMP in‑process, release, and stability testing using HPLC/UPLC, residual ELISA, and other qualified analytical methods.

• Execute testing in accordance with approved methods, protocols, and SOPs, maintaining complete and contemporaneous GMP records.

• Independently perform complex assays, troubleshoot method and instrument issues, and support laboratory investigations.

• Contribute to analytical development and nonclinical testing supporting IND‑enabling, CMC, and BLA programs.

• Author and revise analytical methods, and support method development, qualification, validation, and transfer in alignment with applicable ICH guidance and internal quality standards.

• Document deviations and contribute to root‑cause investigations and CAPA implementation.

• Review GMP data packages and analytical validation documentation for accuracy, completeness, and compliance.

• Help maintain laboratory readiness by preparing reagents and reference standards, managing supplies, and following safe laboratory practices.

• Perform routine equipment maintenance, monitor calibration status, and coordinate service when needed.

• Train, mentor, and provide technical guidance to junior QC analysts.

• Support regulatory inspections, client audits, and other quality engagements.

• Identify opportunities to improve QC workflows, compliance, and analytical robustness.

What you’ll bring

• Bachelor’s degree in a scientific discipline and 3–5 years of relevant GMP/QC experience, or a master’s degree in a scientific discipline and 1–3 years of relevant experience.

• Hands‑on experience in a GMP‑regulated QC chemistry or analytical laboratory.

• Working knowledge of cGMP requirements, data integrity principles, and applicable ICH and USP analytical guidance.

• Experience with analytical method development, qualification, validation, and/or transfer.

• Ability to troubleshoot analytical assays and resolve instrument‑oriented issues.

• Strong attention to detail and sound judgment in generating, documenting, and reviewing GMP data.

• Clear written and verbal communication skills, with the ability to collaborate across QC and partner functions.

• A practical, problem‑solving approach and the ability to contribute to investigations and effective corrective actions.

• Ability to work independently while contributing to a small, high‑performing team.

• Experience supporting client or regulatory audits is preferred.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work‑related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI‑powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation.

Kelly Services is proud to be an Equal Employment Opportunity and Affilative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.