QC Specialist - Full time & Temporary

Bionova Scientific LLC; United States; On-site; USD 66,124 - 82,656; Full time

Job summary

Bionova Scientific LLC in Fremont, California is hiring a QC Specialist (Temporary – Full Time) to perform cell-based assays, ELISA, and qPCR testing, supporting method qualification, in-process testing, release and stability studies with rigorous GMP documentation.

You will develop, transfer, and validate analytical methods, author protocols and reports, maintain QC records and logbooks, and ensure compliance with GDP, Data Integrity and ALCOA+ across cross-functional teams.

Qualifications

• BS in Biological Sciences or related discipline.
• 5–7 years of experience with Bioassays and/or ELISA; 3–5 years in a regulated QC GMP laboratory environment.
• Proficiency with Bioassay, ELISA, qPCR and proper laboratory documentation.
• Experience with method validation, transfer, and regulatory compliance in a GMP environment.
• Proficiency with SpectraMax and QuantStudio instruments.

Responsibilities

• Perform cell-based assays, ELISA, and qPCR testing to support method qualification, in-process testing, release, and stability studies while maintaining accurate GMP documentation.
• Participate in the development, transfer, and validation of analytical and instrument-based test methods (Bioassay, ELISA, qPCR).
• Author and review technical documents, including method validation/qualification protocols and reports, as well as regulatory filing documents as required by project needs.
• Complete, review, and maintain QC documentation, logbooks, and data records with accuracy and compliance.
• Perform routine equipment maintenance in accordance with established procedures.
• Prepare buffer solutions required for analytical procedures.
• Manage inventory by monitoring stock levels and critical reagents, placing timely orders, and ensuring essential supplies remain available.
• Support the development, revision, and adherence to SOPs, protocols, and quality documentation.
• Independently troubleshoot and resolve issues related to analytical techniques and instrumentation.
• Maintain adherence to GMP and quality standards.
• Support regulatory inspections and contribute to observation responses.
• Identify and implement process improvements to enhance efficiency and robustness of bioassay testing.

Skills

Bioassays

ELISA

qPCR

Documentation

GMP

Data Integrity

GDP

ALCOA+

SpectraMax

QuantStudio

SOPs

Regulatory compliance

Education

BS in Biological Sciences

Tools

SpectraMax

QuantStudio

Job description

Bionova Scientific LLC – QC Specialist (Temporary – Full Time)

Location: Fremont, California

Responsibilities

• Perform cell‑based assays, ELISA, and qPCR testing to support method qualification, in‑process testing, release, and stability studies while maintaining accurate GMP documentation.
• Participate in the development, transfer, and validation of analytical and instrument‑based test methods (Bioassay, ELISA, qPCR).
• Author and review technical documents, including method validation/qualification protocols and reports, as well as regulatory filing documents as required by project needs.
• Complete, review, and maintain QC documentation, logbooks, and data records with accuracy and compliance.
• Perform routine equipment maintenance in accordance with established procedures.
• Prepare buffer solutions required for analytical procedures.
• Manage inventory by monitoring stock levels and critical reagents, placing timely orders, and ensuring essential supplies remain available.
• Support the development, revision, and adherence to SOPs, protocols, and quality documentation.
• Independently troubleshoot and resolve issues related to analytical techniques and instrumentation.
• Maintain adherence to GMP and quality standards.
• Support regulatory inspections and contribute to observation responses.
• Identify and implement process improvements to enhance efficiency and robustness of bioassay testing.

Qualifications

• BS in Biological Sciences or a related discipline.
• 5‑7 years of experience with Bioassays and/or ELISA, and 3‑5 years in a regulated QC GMP laboratory environment.
• Strong hands‑on experience with Bioassay, ELISA, qPCR, proper laboratory documentation, and safe laboratory practices; proven experience in method validation, transfer, and regulatory compliance in a GMP environment.
• Proficiency with SpectraMax and QuantStudio instruments.
• Ability to follow and execute SOPs, protocols, and regulatory requirements.
• Ability to interpret data and communicate results clearly.
• Strong quality mindset, including knowledge of GDP, Data Integrity principles, and ALCOA+.
• Knowledge of quality standards and global regulatory guidelines.
• Experience with deviations, CAPA, change control, and related quality systems.
• Demonstrated ability to work independently and collaboratively on cross‑functional teams, with strong analytical and logical problem‑solving skills.
• Effective verbal and written communication skills.
• Self‑motivated, organized, and able to manage multiple tasks in a fast‑paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Working Conditions

This position requires working in a lab/office setting. The role involves walking, standing, stooping, kneeling, and crouching, and occasionally lifting or moving up to 20 pounds independently.

Compensation

Base compensation range: $48 to $60 per hour, influenced by experience, performance, and business factors.

Equal Opportunity Employer

Asahi Kasei is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected characteristic.