Quality Control Lab Analyst I - (Part-Time)

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.

Job Summary

The Lab Analyst I performs laboratory analyses for the purpose of releasing in-process and finished product batches, effecting raw material release, assessing stability, qualifying equipment, evaluating water quality, and supporting production. 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. 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. Works under the immediate supervision of the Quality Control Supervisor.

Principal Responsibilities

• Sample analysis and reporting for raw materials, in process 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.

Required Education, Experience & Skills

• BS in Science or related technical science degree with at least 1 year of laboratory experience is recommended but, not required. Experience in a medical device or pharmaceutical manufacturing laboratory strongly preferred.
• Must possess accurate and proficient analytical skills and ability to work in a heavily regulated environment.
• Must demonstrate appropriate written and verbal communication skills and good personal interactions.
• Must demonstrate competency in the operation, maintenance, qualification, and troubleshooting of lab equipment.
• Must be able to follow written instructions in English with attention to detail.
• Willing to work shifts, including weekends/overtime as required
• Must complete required training as identified on Learning Plan.
• Must be able to pass background/drug check

Additional Preferred Experience

• 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.