Quality Assurance Manager

Job Description:

Continental Services Group (CSG) is a private commercial blood bank in business for over 53 years, servicing pharmaceutical and research companies all over the world. CSG is looking for a Quality Assurance Manager to help ensure all company procedures and products meet internal and external expectations. These standards include legislative and and quality requirements as deemed by FDA, CLIA/COLA, ISO 9001:2015, customer requirements and other relevant bodies. This individual reports to the Quality Assurance Director and is expected to work in a highly hands-on fashion with all staff, in all areas of the the blood bank. The QA Manager's responsibilities include working with the Quality Coordinator to ensure internal audits are being completed, assisting in the revision of Standard Operating Procedures (SOP's), helping with the training of staff in various procedures and hosting FDA, ISO and customer audits. This position is based in the Miami center, but the position occasionally requires visiting the Fort Lauderdale center. 

Your Responsibilities Will Include:

• Perform QA Audits: The QA Manager performs internal and/or external audits, per defined audit schedules to ensure proper adherence to established product specifications, procedures, customer specifications and other quality attributes. The QA Manager is expected to present documented evidence of the audit findings to management.
• Collaborate Preventative and Corrective Action Efforts: The QA Manager is also responsible for assisting staff and managers to assess risk and create corrective action plans to be tracked, and subsequently measured for effectivity. This process is expected to be documented in Continental's QMS platform.
• Assist in Document Control & Databases: The QA Manager assists in the maintenance of SOP's and various databases tracking Calibration Requirements, etc. When SOP's require revisions, the QA Manager is expected to work with various staff to make corrections, review for approval, and circulate amongst staff as appropriate. 
• Train Staff in Quality Objectives: The QA Manager is expected to assist in the training of all staff in the principles and expectations of meeting quality standards.
• Create Analytical Reports: The QA Manager may be asked to extract information from the calibration database, corrective action database, and other programs to generates clear reports for management, executives, and/or clients, as requested.

Ideal Candidates Meet the Following Requirements: 

This position requires a candidate with QA experience in an FDA regulated medical industry. This individual must be proactive, collaborative and have excellent communication skills. This individual must also be open to performing various tasks that may occasionally fall outside of QA. Essential job skills include:

• Technical writing – this position requires a strong grasp of formal English and excellent writing and editing skills. Spanish fluency is a plus.
• Auditing Skills – this position requires an individual with previous auditing skills to established controlled documents; experience with FDA, CLIA and/or ISO 9001 is a plus.
• Analytical thinking – this position requires and individual to draw perform strong root-cause analysis through various methods, extract relevant data to provide accurate reporting of KPI and Company Objective progress. This individual must be astute at identifying patterns occurring in documented issues in the QMS system, and is expected to work with various individuals to develop viable solutions, while adhering to deadlines.
• Communication skills – this position requires an individual who works well with staff, fellow management and customers on a daily basis. This individual should be able to foster strong relationships with staff workers performing operations, to allow for an open dialogue between Operational and Quality individuals. 
• Self-motivation – this position requires the individual to be flexible and largely self-directed once understanding the objectives of the CEO. The QA Manager is expected to be able to fully form proposed solutions independently to present to the CEO for approval of execution.
• Education and Training – this position requires a candidate who has had at least two years of experience in an FDA regulated industry and four years of college in a science related degree.
• Computer Literacy – this position requires someone who is highly proficient in Microsoft Office.
• Regulatory Experience – this position requires who is familiar with navigation of FDA CFR's, and ideally familiar with CLIA and ISO 9001 requirements. 

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 8:00am - 5:00pm. On Fridays, our working hours are roughly 8:00am-2:00pm. Generally, you will not be asked to work weekends, nights, or to be on call.
• You’ll Be Provided with Benefits: After a probationary period, you have the option to partake in the health insurance we provide. You also will have the option to start a 401k, all expenses of setting up the account covered by us. You’ll also have access to profit sharing. 

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.
• 401k - Matching benefits and Roth program available; all administrative and investment fees are paid for by Continental; 
• Health Insurance - Continental pays for a vast majority of the Health Insurance package for our full time employees; this includes Health, Vision, Dental and Health Gap insurance.

About Continental Services Group Inc.:

We are an FDA registered commercial blood bank that has been in business for over 52 years, with a particular respect and eye for Quality. 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 registered facility since 1971, holding multiple city, state and federal licenses, and has been ISO 9001 certified since 2003. To learn more, visit www.continentalbloodbank.com.

Salary : $100