Quality Assurance Manager

Continental Services Group (CSG), a private, FDA-registered commercial blood bank, is seeking an experienced Quality Assurance Manager to join our team and strengthen our Quality Management System. This role closely partners with management and staff across all departments to ensure compliance, drive continuous improvement, and continue to ensure the organization meets regulatory and customer requirements. If you’re passionate about CAPA management, SOP development, staff training and ensuring compliance in an FDA-regulated environment, this role offers the chance to make a direct impact!

Key Responsibilities:

• 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.

Qualifications:

• 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 You Can Expect from Us:

• You’ll Be Treated Fairly-- We are a family-owned and operated company, and we consider each of our employees as part of our larger family. We operate and make our decisions based on merit, qualifications and performance.
• You’ll Be Challenged-- We hold very specialized and several regulatory licenses, which means our work environment is constantly evolving as agencies continue to update and improve their standards.
• You'll have Phenomenal Hours-- We will not ask you to operate outside of our standard working hours, which are roughly 7:30am - 5:00pm. On Fridays, our working hours are roughly 7:30am-3:00pm. You will not be asked to work weekends, nights, or to be on call on any regular basis.
• You’ll Be Provided with Benefits-- After a probationary period, you have the option to partake in the health insurance plans we provide. You also will have the option to start a 401k, all expenses of setting up the account covered by us.

What We Expect From You:

• Communication - We feel this is the most important aspect of any job. You must be in communication with your supervisor, and make sure they are familiar and in agreement with your everyday tasks.
• Timeliness - Everything we do--from shipping out specialty products to scheduling specific donors--is on a schedule. While we are very flexible in terms of time off and scheduling, we operate on the assumption that our employees will be timely, and if necessary, gives plenty of notice of their future absence.
• Team Work - Our operations, testing and systems are complex and multifaceted, so we expect you to work well with our current team members--from those in the lab to those in administration--to ensure we work most cohesively.
• Flexibility - We have two centers: our home office in Miami, and a second in Fort Lauderdale. We expect that if necessary, you are willing to work at either location, in the case of an emergency. Your gas and time would be compensated for a short period, if we ask that you work in a station that is not your home station. We also expect that you’ll be willing to jump in anywhere in the office where we might need you.
• Willingness to Learn - While we expect you’ll come in with a variety of basic skills, we ask that you come also knowing you’ll learn a lot here. 

Salary & Benefits

• Competitive salary within the field. Final determination will depend on experience level and qualifications.
• Profit Sharing & 401k after 1-Full Year of Service - Fully funded and invested. All administrative and investment fees are paid for by Continental.
• Health Insurance - A majority of the insurance fees is paid for by Continental. This includes gap, vision and dental insurance. We can talk to you about what kind of plan will work for you.

About Continental Services Group Inc.

We are an FDA-licensed company that has been in business for over 55 years. We provide blood components and other biological raw materials to our customers, who use the material for the further manufacturing of in-vitro diagnostic products. The vast majority of the product we sell is used for manufacturing test kits and controls, which are used in hospitals around the world. Holding some of the industry's most specialized certifications, we draw the blood and other raw material from a wide base of donors, a majority of which repeatedly and consistently visits every 56 days. This repeat-donor base allows us to provide extensively tested and unique products to the pharmaceutical industry.

Continental has been an FDA licensed facility since 1971, holding multiple city, state and federal licenses. Our laboratory is CLIA certified since 1971, and our facilities have been ISO 9001 certified since 2003. Continental Services Group is an Equal Opportunity Employer and maintains a smoke and drug-free workplace. All offers of employment are contingent upon successful completion of drug and background checks.