QC Microbiology Analyst

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. Our dedication to quality and safety drives everything we do, fostering a dynamic environment where your role is crucial in advancing healthcare solutions.

Job Description:

What You Will Achieve

In this role, you will:

• Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring. 

• Responsible for calibration and use of laboratory instrumentation. 

• Complete documentation associated with analytical results in a timely manner. 

• Report and document any non-conformances to the QC Manager. 

• Assist in the preparation and review of area documentation e.g. SOP's, Reports, Protocols.  

• Assist in the training of other analysts.  

• Ensure training compliance within assigned work area and QC. 

• Perform and assist in additional duties as directed by the QC Manager. 

• Ensure relevant assays are performed on samples in support of release test and stability test programs.  

• Support any validation and qualification of test methods and processes.  

• Facilitate laboratory investigations and support associated product investigation. 

• Support Laboratory inspection and audits. 

• Troubleshoot laboratory methods and instrument problems.  

• Establish and monitor trend analysis program.  

• Contribute to the operations of the Quality Control Laboratories.  

• Liaise with all customers both internal and external. 

• Record and review laboratory testing documentation to cGMP standard. 

• Implement and adhere to appropriate levels of cGMP within the laboratory.  

• Promote safety awareness and the established culture of IIF within the assigned work area. 

• Ensure that sample analysis is conducted to meet batch disposition requirements. 

Here Is What You Need (Minimum Requirements)

• Third level Qualification in Science, Engineering or equivalent is preferred though not essential.  Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel) 

• Excellent communication and interpersonal skills 

• This job description indicates the general nature and level of work expected of the incumbent.  It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent.  Incumbents may be asked to perform other duties as required 

Bonus Points If You Have (Preferred Requirements)

• Bachelor's Degree

• Experience in quality control within a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.

• Proficiency in computer applications, including MS Office, Excel, Laboratory Information Management System, Access, and Trackwise

• Demonstrate the GC OWNIT values 

• Adhere to all HR Policies as appropriate 

• Personal  Development plans focusing on the 70:20:10 guidelines 

• CI tools/- capability is a key building block for learning & development - Trained and M1 certified. 

• Proactive engagement with key stakeholders. 

• Best practices developed and shared with other teams /sites. 

• Best practices actively sought and copied. 

• Proactive & effective communication within and across shifts 

  
Work Location Assignment: On Premise

Work Location Assignment: On Premise

Quality Assurance and Control