Job Details

This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

120,000.00 / yr – 150,000.00 / yr

Direct message the job poster from Kelly

Kelly® Science & Clinical is seeking a Quality Control Specialist for a direct hire opportunity with a leading synthetic biology company in the Bay Area. 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: Onsite in Redwood City, CA

Position Title: Quality Control Specialist I

Position Type: Direct hire

Overview

The Quality Control Specialist I plays a pivotal role in ensuring product integrity and regulatory compliance by performing and overseeing key quality control activities. This includes leading analytical testing, method validation, and coordination with external partners. The position contributes to operational excellence through the development of standard operating procedures (SOPs), implementation of 5S principles, and meticulous daily laboratory maintenance, creating an efficient and well‑organized QC environment. By managing investigations, qualifications, and documentation, the specialist helps mitigate risks and drive continuous improvement across the organization.

Responsibilities

• Conduct analytical testing of in‑process samples, finished products, and stability studies according to established protocols.
• Lead analytical method validation activities by serving as a subject‑matter expert for method development and validation.
• Oversee analytical testing performed by external contractors, ensuring compliance with quality standards and timely completion.
• Support ongoing application and maintenance of 5S principles to enhance operational efficiency and organization in the QC laboratory.
• Create and update quality control SOPs, protocols, and technical reports, including stability studies, qualification documents, and summary reports.
• Perform daily laboratory responsibilities such as data review, equipment maintenance, sample receiving/disposal, and upkeep of monitoring devices.
• Participate in laboratory investigations, including out‑of‑trend/out‑of‑specification events, deviations, change controls, and corrective/preventive actions (CAPA).
• Qualify controls, reference materials, and critical reagents to support rigorous quality standards.

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry, Biological Sciences, or a closely related discipline.
• Minimum 8 years' industrial experience in a quality control function within the life sciences, biotechnology, or synthetic biology sector.
• Sound understanding of CgMP, ICH, and ISO guidelines related to laboratory operations and Good Documentation Practices.
• Demonstrated proficiency with analytical techniques such as enzymatic assays, ELISA, HPLC, LC/​MS, GC, Karl Fischer titration, UV‑Vis spectroscopy, qPCR, CE‑SDS, and electrophoresis.
• Excellent interpersonal communication skills with the ability to collaborate cross‑functionally and present complex technical information effectively.
• Proven experience in authoring and reviewing validation protocols and technical documents supporting analytical method validation.
• Exceptional attention to detail with a commitment to maintaining high standards of documentation, procedural accuracy, and data integrity.
• Ability to manage multiple priorities, deliver results on tight timelines, and uphold compliance standards.

Why this Opportunity?

Join a forward‑thinking team driving innovation in biotechnology and synthetic biology. This role offers an exciting chance to make a direct impact on quality and product excellence in a rapidly evolving scientific environment.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.

Seniority level

Associate

Employment type

Full‑time

Job function

Quality Assurance, Analyst, and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing