Specialist I, Quality Assurance
The Specialist I, Quality Assurance at Confidential Client supports the implementation and management of quality systems including deviations, change controls, CAPAs, and document control to ensure compliance with regulatory standards. This entry-level role assists in batch disposition, quality documentation, and continuous improvement initiatives within a GMP-regulated biotechnology manufacturing environment, contributing to the delivery of high-precision cell therapy products.
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.
What You’ll Do
Confidential Client is hiring an entry-level Specialist I, Quality Assurance to support day-to-day quality operations at their Sacramento, CA manufacturing site. This role supports implementation and administration of quality processes to help ensure products meet cGMP standards and internal policies.
- Assist with management and documentation of quality systems: deviations, change controls, CAPAs, and document control.
- Support investigations of deviations by collecting data, documenting findings, and helping draft root-cause analyses and corrective actions.
- Assist in batch disposition activities by reviewing batch records, compiling release data, and liaising with manufacturing and QC teams to resolve quality questions.
- Help maintain the document management system and prepare documentation for audits and inspections.
- Provide basic training and guidance to production staff on quality procedures and proper documentation practices.
- Participate in continuous improvement initiatives and track progress on quality-related corrective actions.
Responsibilities
- Quality system support: document and track deviations, change controls, CAPAs, and other quality events.
- Batch disposition support: help evaluate batch records and recordkeeping to support product release decisions.
- Document control: maintain accuracy of controlled documents and support audit readiness.
- Investigations: support timely root-cause investigations and help implement corrective/preventive measures.
- Cross-functional collaboration: work with manufacturing, QC, and R&D to resolve quality issues and improve processes.
- Training & continuous improvement: assist with staff training and contribute to ongoing process improvements.
Qualifications
- Bachelor’s degree in a relevant scientific field (biology, biochemistry, immunology, or similar).
- 1–3 years of experience in quality control, analytical development, or GMP manufacturing environments preferred.
- Basic knowledge of FDA regulations, cGMP requirements, and quality system processes.
- Experience or exposure to deviations, CAPA, change control, and document control is a plus.
- Strong organizational skills, attention to detail, and commitment to data integrity.
- Effective verbal and written communication skills; ability to work independently and as part of a team.
- Willingness to learn, adapt, and work occasional overtime, weekends, or holidays as needed.
Work Environment & Physical Demands
- This role supports operations at Confidential Client’s Sacramento manufacturing site(s). The position may be designated TELECOMMUTE for portions of work, but candidates must be able to work on-site as required by operational needs.
- Production roles may require cleanroom gowning and adherence to PPE rules (face coverings, gloves, hoods, goggles). Use of cosmetics, jewelry, or facial piercings in GMP cleanrooms may be restricted.
- Some positions may require visual acuity and normal color vision for inspection tasks, and the ability to wear gowning for extended periods.
Compensation & Benefits
- Salary range: $75,000 - $90,000 per year (based on experience, education, location, and other job-related factors).
- Eligible full-time employees may receive pre-IPO equity, annual bonus, medical/dental/vision benefits, PTO, 401(k), life and disability coverage, and parental leave.
- Additional on-site perks may include subsidized meals and snacks.
Who We Are
Confidential Client is focused on developing and manufacturing next-generation cell therapies with a patient-first mission. The company values passion, courage, integrity, and an entrepreneurial spirit. This role offers a strong foundation for growth in a fast-paced, science-driven environment.
Notice to Staffing Firms
Confidential Client does not accept unsolicited resumes from staffing agencies without a written agreement and specific engagement for a particular opening. All candidate submissions should go through the official talent or HR channel.
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.
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