Tucker Parker Smith Group (TPS Group) ยท 3 hours ago
Quality Specialist
Hercules, CA
Contract
Onsite
Entry, Mid Level
$40/hr - $45/hr
2+ years expTucker Parker Smith Group (TPS Group) is a global leader in life science research and clinical diagnostics, developing innovative products used in laboratories, hospitals, and manufacturing environments worldwide. The Quality Specialist II plays a critical role in supporting Quality Operations through hands-on engagement and strategic oversight, ensuring products and processes meet internal quality standards and regulatory requirements.
Staffing & Recruiting
Hiring Manager
Ted Hurvul
Responsibilities
Support daily Quality Operations by attending Tier 2 Gemba meetings and providing real-time quality guidance to manufacturing teams
Perform batch record reviews and support product release activities
Review and approve stability studies, labeling documentation, FAIs, and field bulletins
Ensure training compliance and maintain quality documentation in regulated systems
Chair Material Review Board (MRB) meetings and coordinate nonconformance investigations and Quality Notifications (QNs)
Participate in Environmental Control Meetings and support contamination and process control initiatives
Support internal and external audits, including audit readiness and response coordination
Compile, analyze, and update quarterly quality metrics and reports
Collaborate cross-functionally to identify root causes, implement corrective actions, and mitigate quality risks
Qualification
Required
Associate degree or equivalent in Biology, Chemistry, or a related scientific field
2+ years of experience in a regulated manufacturing environment, or an equivalent combination of education and experience
Working knowledge of GMP and quality system standards (ISO 13485, FDA 21 CFR 820/210/211)
Experience with device, drug, or biotech manufacturing processes
Hands-on experience with nonconformance investigations, deviation management, batch record review, and product release
Proficiency with QMS databases, SAP, Veeva, and Microsoft Office
Strong attention to detail, organization, time management, and communication skills
Company
Tucker Parker Smith Group (TPS Group)
The Tucker Parker Smith Group ( TPS Group), is a professional recruiting and staffing firm.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brian Smith
Co-Founder & Managing Partner
N
Nichole Tonning-Smith
Co-Founder & Chief Operations Officer
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