21876 – Lead QC Micro Analyst – Limerick Full Time

Purpose:

Performs investigations related to cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

Responsibilities:

• Supports manufacturing personnel in the identification of microbiological root cause analysis and provides technical advice on QC related topics as needed.
• Technical writing assignments such as laboratory investigations, SOPs, trend reports, risk assessments, etc.
• Performs peer review of data.
• Performs laboratory investigation reports.
• Microbiology representation and participation in cross functional site meetings.
• Performs bioburden and endotoxin testing review of products and raw materials.
• Supports Product Testing and environmental monitoring sampling as required.
• Assists in coordinating equipment maintenance and calibration.
• Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking.
• Participates in training of other new employees and prioritizes daily workload.
• Performs all duties relevant to the Quality Control Microbiology Analyst position as required.
• Provides on-the-floor mentorship and support to employees.
• Ensures employees timesheets are completed on time.
• Supervises employees training to ensure that all requirements are met, including OJT.
• Maintains up to date training records for self and direct reports.
• Scheduling of daily tasks for analysts.
• Performs monthly performance feedback meetings with direct reports.
• Raises all performance issues to management and/or HR.

Minimum Qualifications and Experience: 

• A third level qualification (BSc degree or higher) in Microbiology or related field. Will substitute relevant work experience in lieu of degree requirement.
• Requires 2+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.
• Excellent communication skills, both verbal & written.
• Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
• Adaptable and flexible, as position may require some travel.
• Collaboration and teamwork. Maintains the highest standards of ethical behaviour.
• Results and performance driven.
• Strong analytical ability and associated problem solving.
• Good time management and attention to detail.
• Knowledge and proficient in the use of Microsoft products including, Project, Excel, Word and PowerPoint.

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