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Job Description
**Job Summary:**
Highly skilled QC Micro Analyst required to perform microbiology, chemistry, and biochemistry testing in a regulated pharmaceutical facility.
The ideal candidate will have a strong technical background in analytical techniques and laboratory equipment, with experience in microbiological, chemistry, and biochemistry testing of Bulk API and final drug product.
**Responsibilities:**
• Perform a wide variety of microbiology, chemistry, or biochemistry testing to support utilities, raw material, in-process, bulk, and drug product release.
• Rapidly turnaround samples to meet manufacturing needs.
• Review and approve data.
• Provide support and advice to manufacturing on QC-related topics.
• Initiate and lead investigations where required.
• Complete CAPAs and Change Controls in accordance with site procedure.
• Write new and update current procedures on electronic documentation system.
• Provide training to other analysts and manufacturing personnel.
• Present technical analytical data clearly and concisely to customers, internal investigations, and regulatory inspectors.
• Proactively identify and implement lab process improvements.
• Support lean initiatives in lab operations, including standard work, level loading, test method execution, documentation updates, and equipment qualification.
• Support Team leader on day-to-day testing operations.
**Preferred Testing Experience:**
• Bioburden
• Endotoxin
• Sterility Testing
• Microbial Identification using genetic methods
**Key Competencies:**
• Adaptable and flexible
• Collaboration and team work
• Maintains the highest standards of ethical behaviour
• Clear communication skills
• Results and performance driven
• Holds self accountable for compliant and flawless execution
• Problem solving and attention to detail
• Good time management
• Good organisational skills
• Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc.
**Qualifications and Experience:**
• Third-level qualification (Minimum: Primary degree in a science discipline)
• A minimum of 2 years experience within the Pharmaceutical Industry
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products
• Skills: Endotoxin bioburden Sterility Testing