Qc Micro Analyst Job In Cork

QC Micro Analyst role at a leading bio-pharma company in Cork, requiring 2 years' pharmaceutical industry experience, with a focus on microbiological, chemistry, and biochemistry testing.

Job Description

We are seeking a highly skilled QC Micro Analyst to join our team in Cork. The successful candidate will have a strong background in microbiological, chemistry, and biochemistry testing, with a minimum of 2 years' experience in the pharmaceutical industry.

• Perform a wide variety of microbiology, chemistry, or biochemistry testing to support utilities, raw material, in-process, bulk, and drug product release.
• Rapid turnaround of samples to meet manufacturing needs.
• Perform data review and approval.
• Initiate and lead investigations where required.
• Initiate and complete CAPAs and Change Controls in accordance with site procedure.
• Write new and update current procedures on electronic documentation system.
• Present technical analytical data clearly and concisely to customers, internal investigations, and regulatory inspectors.
• Support lean initiatives in the area of lab operations, including standard work, level loading, test method execution, documentation updates, and equipment qualification.

Preferred experience in bioburden, endotoxin, sterility testing, and microbial identification using genetic methods. Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, and Trackwise is desired.

Qualifications and Experience

Third-level qualification (minimum: primary degree in a science discipline) and a minimum of 2 years' experience within the pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.