Biotech QA Specialist: QC & Compliance

Bionova Scientific; Fremont (CA); On-site; USD 49,593 - 66,124; Full time

Job summary

Bionova Scientific LLC is seeking a QA Specialist in Fremont, CA to provide Quality Assurance for QC and Analytical Laboratories in a fast-paced CDMO. You will handle investigations, self-inspections, data reviews, and change control in GMP environments.

Qualifications include a Bachelor’s in sciences, 2–4 years GMP-related experience, and strong documentation/communication skills. The role supports cGMP audits and document control tasks within a collaborative team.

Qualifications

• Bachelor’s or higher degree in sciences.
• 2-4 years of GMP experience in biotech/pharma.
• Experience with QA systems and processes.
• Strong technical writing skills.

Responsibilities

• Perform batch related records review.
• Perform QA release of raw materials in QAD ERP System.
• Evaluate compliance of completed manufacturing records and QC results.
• Evaluate document changes for SOPs, MBRS, specs, test methods.
• Review deviations, CAPAs, and change controls.
• Support and conduct training and audits as needed.

Skills

GMP knowledge

Quality Assurance

Document control

Change control

Batch records review

QA release

Education

Bachelor’s degree in sciences

Tools

SharePoint

Visio

Project

Acrobat Pro

Master Control

Job description

Bionova Scientific LLC is seeking a QA Specialist in Fremont, CA to provide Quality Assurance for QC and Analytical Laboratories in a fast-paced CDMO. You will handle investigations, self-inspections, data reviews, and change control in GMP environments.

Qualifications include a Bachelor’s in sciences, 2–4 years GMP-related experience, and strong documentation/communication skills. The role supports cGMP audits and document control tasks within a collaborative team.