Quality Assurance Manager
7 days ago
Location: Miami, FL (with occasional travel to Fort Lauderdale)
Company: Continental Services Group (CSG)
About Us
Continental Services Group (CSG) is a private, FDA-registered commercial blood bank that has been serving pharmaceutical, diagnostic development and research companies worldwide for over 50 years. We specialize in providing high-quality blood components and biological materials that support the development of diagnostic products used in hospitals and medical facilities worldwide. With FDA, CLIA/COLA, and ISO 9001 certifications, we take pride in our long-standing commitment to quality and regulatory excellence.
The Opportunity
We are seeking an experienced Quality Assurance Manager to join our team and strengthen our Quality Systems. This is a hands-on role that will partner closely with staff across all departments to ensure compliance, drive continuous improvement, and prepare the organization for regulatory and customer audits. If you're passionate about CAPA management, SOP development, and ensuring compliance in an FDA-regulated environment, this role offers the chance to make a direct impact.
What You'll Do
- Lead CAPA & Risk Management: Drive corrective and preventive action (CAPA) investigations, assess risk, and ensure effective closure and follow-up.
- Own SOPs & Document Control: Revise, maintain, and oversee controlled documents; collaborate with staff to ensure accuracy and compliance.
- Conduct Internal Audits: Plan and execute audits to FDA, CLIA, ISO 9001, and customer requirements; present findings and corrective actions to leadership.
- Support Regulatory Readiness: Host and support external audits from FDA, ISO, and customers.
- Train & Educate Staff: Deliver training on SOPs, QMS principles, and quality culture expectations.
- Provide Data & Insights: Analyze QMS data, calibration records, and KPIs to identify trends and provide clear reports to management.
What We're Looking For
- Experience: 3+ years in Quality Assurance within an FDA-regulated industry (biologicals experience strongly preferred).
- Technical Skills: Hands-on CAPA management, SOP writing/revisions, internal auditing, and quality planning experience.
- Regulatory Knowledge: Familiarity with FDA CFRs, ISO 9001, and CLIA; experience hosting or supporting regulatory inspections.
- Education: Bachelor's degree in a science-related field.
- Other Skills: Strong technical writing, root cause analysis, and communication skills; ability to work independently and collaboratively.
- Bonus: Spanish fluency.
What We Offer
- Competitive Pay: Based on experience and qualifications.
- Work-Life Balance: Standard weekday hours (Mon–Thu 8am–5pm, Fri 8am–2pm). No nights, weekends, or on-call.
- Comprehensive Benefits: Health, vision, dental, and gap insurance (majority employer-paid).
- Retirement & Profit Sharing: 401(k) with profit-sharing opportunities.
- Supportive Culture: Family-owned company with a collaborative, respectful, and merit-based environment.
Why Join Us
At CSG, you'll join a team where Quality isn't just a department — it's our reputation. You'll be empowered to help reshape and continue quality processes, contribute to international healthcare impact, and grow within a stable and respected organization that's been thriving for more than five decades.
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