Quality Specialist II (Richmond)

Quality Specialist II Location:

Onsite Schedule:

Monday–Friday, 8 AM–5 PM Contract Length:

6 months Compensation:

$40–$45 per hour

Position Overview The Quality Specialist II plays a key role in daily Quality Operations, combining hands‑on support on the production floor with broader oversight of compliance and documentation activities. This role requires strong collaboration, attention to detail, and the ability to influence cross‑functional teams to maintain product integrity and regulatory compliance. A typical day includes participating in Tier 2 Gemba meetings, supporting manufacturing teams in real time, reviewing batch records, releasing product, and approving stability studies and labeling. The specialist also leads MRB meetings, ensures training compliance, coordinates Quality Notifications, participates in Environmental Control Meetings, supports audits, and updates quarterly quality metrics. How You’ll Make an Impact Ensure Compliance & Reduce Risk Maintain adherence to internal quality standards and external regulatory requirements. Provide real‑time quality support to manufacturing teams to prevent issues before they escalate. Improve Product & Process Quality Review batch records, manage quality documentation, and support root cause investigations. Identify systemic issues and contribute to corrective and preventive actions. Serve as a Regulatory Subject Matter Expert Act as the primary compliance expert for assigned products in alignment with ISO 13485. Provide guidance on labeling, documentation, and regulatory expectations. Support Internal & External Audits Prepare documentation, coordinate responses, and ensure audit readiness. Assist with requalification activities and timely delivery of required quality records. Drive Strategic Quality Planning Work independently while collaborating across departments. Analyze quality data, implement standards, and document results in regulated formats. What You Bring Required Qualifications Associate degree (or equivalent) in Biology, Chemistry, or a related scientific field 2+ years of experience in a regulated manufacturing environment, or equivalent education/experience Familiarity with GMP and quality system standards (ISO 13485, FDA 21 CFR 820/210/211) Working knowledge of device, drug, or biotech manufacturing processes Experience with: Nonconformance investigations Deviation management Batch record review Product release Proficiency with QMS databases, SAP, Veeva, and Microsoft Office Strong attention to detail, multitasking ability, time management, and communication skills