Quality Control Analyst jobs in South Carolina

Description

About Us

Rockwell Medical (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide. Our mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. We are focused on innovative, long-term growth strategies that enhance our products, our processes, and our people, enabling us to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Our products are vital to vulnerable patients with end-stage kidney disease, and we are relentless in providing unmatched reliability and customer service.

Joining the Team

Thank you for considering this opportunity to join our team.  At Rockwell Medical, we work to foster an innovative, collaborative, and inclusive culture where everyone feels valued and empowered to succeed.  We foster fresh ideas and encourage our team members to think outside the box.  We are committed to professional development and offer opportunities at every level to make a real difference. Our employees positively impact our company, our customers, and the patients they serve.  We understand the importance of maintaining a healthy work-life balance.  While we are passionate about what we do, we equally value your well-being to ensure you have the opportunity to enjoy what matters most outside of work.  In addition to offering competitive pay, we provide a comprehensive benefits package that includes health and dental insurance, retirement plans and other offerings to support your financial wellness and overall health. 

Qualifications

Job summary: 

The role of Lab Analyst II is an additional set of expectations and duties to those associated to the Lab Analyst I role. 
Experienced laboratory analyst that performs chemical and microbial analyses of in-process and finished product batches, raw materials, assessing stability, and monitoring for environmental control, as well as supporting validations of equipment and materials. Must be knowledgeable of microbiological techniques, analytical instrumentation and wet chemistry techniques and analysis. Testing experience includes ICP, AA, Polarimeter, titration, kinetic endotoxin assay, microbial recovery methods, and other analytical methods. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Must have the ability to work collaboratively, multitask, and adapt to changing priorities and schedules. The Lab Analyst II position works with other departments, such as Operations, Shipping, Receiving, and Quality Assurance to assure the support of the laboratory on various projects, studies, and routine tasks. May train less-senior staff.  Employee must demonstrate understanding of the compliance requirements applicable to medical device product manufacture and testing, such as cGMP, cGLP, USP, and AAMI/ISO.  Work responsibilities must be performed in accordance with regulatory and industrial standards, and in a timely manner with a high regard for safety and quality.  Strong time management skills, accuracy and strict attention to detail is mandatory to meet performance expectations. Performs a variety of chemical tests and is knowledgeable with instrumental techniques. Relies on work instructions and pre-established guideline to perform the functions of the job.  Accurate testing on the first attempt under pressure of production details is required.  Must demonstrate ability to accurately review, interpret and report data and to ensure timely and accurate review of other analysts’ documentation. Reports to the Quality Control Supervisor. 

Responsibilities: 

• Sample analysis and reporting for raw materials, inprocess goods, water monitoring samples, and finished product. 

• Performs sample analysis and qualification of prepared test standard solutions in a timely manner, with emphasis on attention to detail and accuracy of execution.  

• Cross-trains and develops proficiency in all instrument methods and test requirements, including ICP-OES, AA, Polarimeter, Acid titrator, kinetic endotoxin assay methods, and other analytical instruments. 

• Accurately records raw data in logs and worksheets. Interprets and documents all test results, calculations and completes report summaries accurately.    

• Reviews results for conformance to standards. Performs second person verification of lab documentation. 

• Executes job responsibilities consistently. Ability to execute tasks by conforming to written instructions and recognize when a deviation from such procedures has occurred.  

• Performs routine instrument calibrations, qualifications, set-up, maintenance, and suitability checks.  

• Able to learn and perform basic trouble shooting skills. Assists in laboratory investigations. 

• Perform tracking and ordering of laboratory supplies.  

• Completes all training prior to execution of activity.  

• Performs regular housekeeping to maintain a clean and safe work area when free time is available. Complies with all safety, health, and environmental rules and regulations.  

• Other duties as deemed necessary to support the business needs of the Company. 

Requirements:   

• BS in Science or related technical science degree with at least 3-5 years of relevant laboratory experience. Experience in a medical device or pharmaceutical manufacturing laboratory strongly preferred. 

• Must be self-directed to work with minimum supervision and ability to work collaboratively, multitask, and adapt to changing priorities and schedules.  

• Must demonstrate very strong accurate and proficient analytical skills and ability to work in a heavily regulated environment. Strong understanding of product specifications and performance attributes is mandatory. 

• Must demonstrate appropriate written and verbal communication skills and good personal interactions. 

• Must demonstrate strong competency in lab instrument operation, maintenance, qualification, and troubleshooting.  

• Must be able to follow written instructions in English with exceptional attention to detail.  

• Willing to work shifts, including weekends/overtime as required 

• Must be able to pass background/drug check  

Expectations/Other skills for this position: 

• Good work history, positive attitude, good attendance record and proven work ethic 

• Safe and efficient equipment operation 

• Strictly comply with Standard Operating Procedures and GMP practices and guidelines 

• Communicate with supervisor and other employees about potential problems or improvements 

• Work well in a team environment, coach/motivate other employees 

• Commitment to continuous improvement 

• Support company culture of quality, accountability, efficiency, and teamwork 

• Internal audit experience or industry certification is a plus.