QC Lab Lead

2 weeks ago

Limerick, Limerick, Ireland Ortec Inc Full time

Are you ready to take the next step in your quality control career? We're looking for a driven and experienced QC Supervisor who is looking to make a significant impact within a fast-paced, ISO/FDA-regulated environment, working with cutting-edge technology and a talented group of professionals. This is a great opportunity for someone who is looking to work in a  start-up environment  and wants to contribute to the success of a new facility

About the Role: As the QC Supervisor , you'll play a key role in directing daily activities in the QC laboratory, ensuring that raw materials, in-process, and finished products are tested and meet industry standards. You'll collaborate closely with the site management team to maintain the flow of work, uphold compliance, and promote continuous improvement. This role offers a chance to not only lead and mentor, but also to work hands-on with advanced analytical instrumentation and directly contribute to the company's success.

Key Responsibilities:

Lead the day-to-day operations of the QC Lab, ensuring timely completion of routine, in-process, and finished product testing. Collaborate with site management to maintain and optimize the workflow schedule for all QC activities. Train, mentor, and develop new QC employees, ensuring proper documentation of training records. Oversee implementation of OOS investigations, CAPAs, and deviations to ensure compliance. Perform advanced chemical testing using state-of-the-art analytical equipment such as HPLC, GC, FTIR, UV-VIS , and troubleshoot as needed. Supervise and support QC Lab Technicians and QC Analysts, offering guidance and leadership. Conduct annual performance reviews and help shape employee development through training and performance improvement plans. Lead efforts to ensure audit readiness and maintain compliance with FDA and ISO regulations. Foster a safe, clean, and organized work environment, driving the 5S principles across the QC lab. Contribute to writing and updating SOPs to ensure cGMP compliance, staying ahead of industry best practices.

What We're Looking For:

. or . in Chemistry or a related field with 2-4+ years of relevant experience in a QC laboratory setting. Proven track record of leadership in an ISO or FDA -regulated environment. Experience in Method Transfer, Method Development, Empower, HPLC, GC and participation in an Audit are required. Experience with LIMS and a solid understanding of cGMP. A proactive problem-solver who thrives in a fast-paced, regulated environment.

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