Quality Assurance Associate

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About the role

This part-time, onsite Quality Assurance Specialist provides quality oversight for manufacturing operations within an ISO-regulated IVD manufacturing environment. The role focuses on detailed review of batch records and manufacturing documentation to ensure accuracy, completeness, and regulatory compliance prior to product release. You will support lot release activities, maintain quality system records, and contribute to investigations and audits that uphold high standards of quality and regulatory compliance.

Responsibilities

• Review manufacturing batch records and associated documentation to ensure accuracy, completeness, and compliance prior to product release.
• Examine raw material inspection records and verify that materials meet established specifications and quality requirements.
• Review equipment calibration documentation to confirm that instruments and equipment are properly calibrated and suitable for use in manufacturing.
• Support lot release activities by verifying that all required quality checks and documentation are complete and compliant.
• Prepare Certificates of Analysis as needed to support product release and customer or regulatory requirements.
• Review and approve quality system records including nonconformance reports (NCRs), corrective and preventive actions (CAPAs), complaints, deviations, and change orders.
• Support and participate in investigations of quality events by identifying discrepancies, gathering relevant data, and contributing to root cause analyses.
• Perform risk assessments related to quality events and verify the effectiveness of implemented corrective and preventive actions.
• Maintain accurate and organized quality records in accordance with ISO standards and regulatory requirements.
• Support internal and external audits by providing documentation, answering quality-related questions, and demonstrating compliance with applicable standards and regulations.
• Participate in training activities to maintain current knowledge of quality procedures, regulatory requirements, and best practices.
• Assist with various quality projects and initiatives as business needs arise, contributing to continuous improvement of quality systems and processes.
• Help maintain compliance with ISO standards and support quality system activities within a regulated IVD/CDMO environment.
• Apply knowledge of 21 CFR 820 regulations to daily quality assurance activities and decisions.
• Collaborate with Operations, Manufacturing, Quality, and leadership teams to ensure alignment on quality expectations and decisions.
• Communicate quality findings and recommendations clearly to both technical and non-technical stakeholders.
• Contribute to document control activities to ensure that procedures, work instructions, and records are current, controlled, and properly implemented.

Requirements

• At least 3 years of quality assurance experience in regulated manufacturing environments.
• Bachelor's degree in Life Sciences, Engineering, Business, or a related field.
• Demonstrated experience with ISO-regulated quality systems, including maintaining compliance with ISO standards.
• Working knowledge of 21 CFR 820 regulations and their application in an IVD or CDMO setting.
• Strong batch record review skills, with the ability to identify errors, discrepancies, and gaps in documentation.
• Hands-on experience reviewing and managing NCRs, CAPAs, complaints, deviations, and other quality events.
• Understanding of GMP, FDA expectations, and regulatory compliance in a manufacturing context.
• Proficiency in quality assurance and quality control principles, including risk assessment and effectiveness checks.
• Strong document control skills, including managing and reviewing controlled procedures and records.
• Ability to interpret regulatory requirements and quality standards and apply them to practical manufacturing and quality decisions.
• Independent problem-solving and decision-making capabilities in a regulated environment.
• Strong communication skills with both technical and non-technical stakeholders.
• Proficiency with computer systems and reporting tools used for quality documentation and data analysis.

Skills

• Preferred knowledge of IVDR and its application to IVD products.
• Experience working in an IVD or CDMO environment supporting genomics, molecular diagnostics, or biotechnology products.
• Familiarity with ISO 13485 or similar ISO standards applicable to medical devices and diagnostics.
• Experience supporting internal and external audits, including preparation of documentation and responses to findings.
• Experience in conducting or supporting root cause analyses and continuous improvement projects.
• Ability to collaborate effectively with cross-functional teams in Operations, Manufacturing, Quality, and leadership.
• Comfort working in a high-visibility quality role with direct influence on product release and regulatory compliance.

Work Environment

This onsite position is based in a regulated IVD/CDMO manufacturing environment in San Diego, CA, supporting cutting-edge genomics, molecular diagnostics, and biotechnology products. The role emphasizes collaboration, regulatory compliance, and continuous improvement, with responsibilities spanning batch review, quality systems, investigations, audits, and change control. You will work closely with Operations, Manufacturing, Quality, and leadership teams in a rapidly growing organization.

Schedule

This part-time role offers a flexible schedule of approximately 20–30 hours per week.

Pay

The pay range for this position is $30.00 - $37.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. If eligible, benefits for this temporary role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)