About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

The Specialist I, Quality Assurance supports the implementation and ongoing management of quality systems in a regulated, high‑precision life‑sciences manufacturing environment. This is an entry-level role focused on documentation, investigations, and batch disposition activities that ensure product quality and regulatory compliance.

• Assist in managing deviations, change controls, CAPAs, and document control.
• Support investigations by collecting evidence, documenting findings, and helping to track corrective actions.
• Help review batch records, assist in evaluating batch release data, and support batch disposition activities.
• Maintain and update the document management system to ensure accuracy and audit readiness.
• Support preparation of quality documentation for internal and external audits and ensure adherence to cGMP protocols.
• Provide basic training and support to manufacturing staff on quality procedures and participate in continuous improvement initiatives.
• Collaborate across manufacturing, QC, and R&D teams to document and address quality issues.

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Qualifications

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, or similar).
• 1–3 years’ experience in quality control, analytical development, or a GMP-regulated environment preferred.
• Working knowledge of FDA regulations, cGMP concepts, and quality system processes.
• Familiarity with deviation investigations, change control, CAPA, and document control is a plus.
• Strong organizational skills, attention to detail, and commitment to data integrity.
• Effective verbal and written communication skills and the ability to work independently and in teams.
• Willingness to learn, adapt, and work scheduled overtime or occasional weekends as required.
• Ability to meet cleanroom gowning and safety requirements when assigned to production areas.

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Location & Work Conditions

This position is based in Sacramento, CA. The role is marked TELECOMMUTE/REMOTE-eligible in the posting but will require the ability to work on-site at the Confidential Client’s Sacramento facilities as operational needs dictate. Candidates must be able to participate in video meetings and may be required to work scheduled overtime, weekends, or holidays.

Physical demands include meeting cleanroom gowning requirements and, for production-associate tasks, sufficient visual acuity and normal color vision for visual inspections in a GMP environment.

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Compensation & Benefits

• Anticipated salary range: $75,000 - $90,000 per year (based on experience, education, location, and other job-related factors).
• Full-time employees are eligible for pre-IPO equity, annual bonus, medical/dental/vision benefits, PTO, 401(k), life & AD&D coverage, and parental leave.
• Additional on-site perks where applicable (e.g., subsidized lunches and snacks).

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Additional information

This role provides a strong platform for career growth in quality assurance within the life‑sciences/biotech manufacturing sector. Confidential Client is committed to quality, patient impact, and a collaborative, high‑integrity culture.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.