Quality Assurance Specialist (GMP Manufacturing/Pharma/Medical Device)

Job Title: Quality Assurance Specialist (GMP Manufacturing/Pharma/Medical Device)

Location: Richmond, CA ( Onsite -**Local candidates only )

Duration: 6-Month Contract ( Great potential for extension)

Pay Rate: $40–$45/hour + Benefits ( Medical, Dental, Vision )

Schedule: Full-time Monday–Friday , 8:00 AM – 5:00 PM

**PLEASE NOTE: ONLY ACCEPTING APPLICANTS WHO ARE LOCAL AND WITHIN COMMUTING DISTANCE TO RICHMOND, CA.

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier live

We are seeking a Quality Assurance Specialist II to join a leading life sciences and diagnostics organization . This position plays a critical role in supporting Quality Operations within a regulated manufacturing environment . The ideal candidate will have experience working in GMP-regulated manufacturing and will be responsible for ensuring compliance with quality systems , regulatory requirements , product release activities , batch record review , audit support , and continuous improvement initiatives .

This role requires a highly detail-oriented professional who can work independently while collaborating closely with Manufacturing , Quality , Regulatory Affairs , Engineering , and Operations teams. The successful candidate will serve as a quality resource on the manufacturing floor, helping drive compliance , product quality , and operational excellence .

Key Responsibilities

• Provide daily Quality Operations support to manufacturing teams and production activities

• Participate in Tier 2 Gemba meetings and provide real-time quality guidance and support

• Perform batch record review and product release activities to ensure compliance with internal procedures and regulatory requirements

• Review, approve, and maintain quality documentation , including stability studies , labeling documentation , FAI documentation , field bulletins , and quality records

• Support manufacturing operations by ensuring compliance with GMP , quality systems , and regulatory standards

• Serve as a quality resource and provide guidance on quality investigations , process improvements , and compliance-related issues

• Participate in Material Review Board (MRB) activities, including reviewing nonconforming materials and supporting disposition decisions

• Coordinate and manage Quality Notifications (QNs) , deviations , and quality events

• Support nonconformance investigations , root cause analysis , CAPA activities , and continuous improvement initiatives

• Review and monitor training compliance records to ensure employees meet quality and regulatory requirements

• Participate in Environmental Control Meetings and support quality oversight activities

• Assist with internal audits , external audits , customer audits , and regulatory inspections

• Support audit readiness activities and ensure documentation remains inspection-ready

• Compile, analyze, and update quarterly quality metrics , dashboards, and performance indicators

• Review quality data and identify trends, risks, and opportunities for improvement

• Ensure compliance with document control procedures , quality standards, and regulatory requirements

• Collaborate with cross-functional teams to support manufacturing goals while maintaining product quality and compliance

• Support implementation and maintenance of Quality Management Systems (QMS) , procedures, and best practices

Required Qualifications

• Associate degree in Biology , Chemistry , Life Sciences , Engineering , or a related technical field (equivalent experience may be considered)

• 2+ years of experience in Quality Assurance , Quality Systems , Quality Operations , Manufacturing Quality , or a related quality role within a regulated industry

• Experience working in GMP-regulated manufacturing environments , including medical device , biotech , pharmaceutical , diagnostics , or life sciences industries

• Experience performing batch record review , documentation review , and product release activities

• Working knowledge of GMP , FDA regulations , ISO 13485 , and Quality Management Systems (QMS)

• Experience supporting nonconformances , deviations , Quality Notifications (QNs) , investigations , and CAPA processes

• Familiarity with manufacturing processes , production workflows , and quality oversight responsibilities

• Experience reviewing and approving quality documentation , controlled records , and manufacturing documentation

• Experience supporting internal audits , external audits , and inspection readiness activities

• Strong understanding of Good Documentation Practices (GDP) and data integrity requirements

• Experience working cross-functionally with Manufacturing , Operations , Engineering , Regulatory Affairs , and Quality teams

• Strong attention to detail , organizational skills, and ability to identify discrepancies and compliance risks

• Ability to manage multiple priorities in a fast-paced manufacturing environment

• Strong verbal and written communication skills with the ability to influence and collaborate across teams

• Proficiency with Microsoft Excel , Word , Outlook , and PowerPoint

• Experience using SAP , Veeva , QMS databases , or similar enterprise systems

Preferred Qualifications

• Bachelor's degree in a scientific or technical discipline

• Experience in medical device , diagnostics , biotechnology , or pharmaceutical manufacturing

• Experience serving as a Quality representative supporting manufacturing floor operations

• Experience leading or participating in Material Review Board (MRB) activities

• Experience with CAPA management , root cause investigations , and risk assessments

• Experience supporting FDA , ISO , customer, or regulatory inspections

• Knowledge of FDA 21 CFR Part 820 , 21 CFR 210 , and 21 CFR 211

• Experience with product labeling review , stability programs , and change control processes

• Experience analyzing quality metrics and identifying continuous improvement opportunities

Soft Skills & Core Competencies

• Strong attention to detail and commitment to quality

• Excellent critical thinking and problem-solving skills

• Ability to work independently while collaborating effectively across teams

• Strong sense of ownership , accountability , and follow-through

• Ability to influence and guide teams on quality and compliance requirements

• Excellent organizational , time-management , and prioritization skills

• Effective communication and relationship-building skills

• Ability to thrive in a cross-functional , regulated manufacturing environment