QC Analyst – Microbiology

About the Company:

Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of
highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech
Manufacturing Sector.
We are now seeking a QC Analyst – Microbiology, to join our multinational client facility based in the
province of Leinster.

About the position:

The successful candidate will be involved in assisting in laboratory operations, performing testing of
samples and performing laboratory duties in accordance with cGMP regulations.

Key Responsibilities:

• Perform cleanroom, BSC & Isolator batch related monitoring
• Utility sampling of water systems and Compressed Air/Gas.
• Carrying out In-Process testing of critical lot related samples to support Manufacturing activities (HPLC and UV Spectrophotometry).
• Issuance, receipt, and testing of biological indicators.
• Reading and reporting of environmental monitoring, BIs, and aseptic qualification sample results.
• Reconciliation and inspection of media fill units, and participation in media fills (APS).
• Carrying out identifications of Microorganisms isolated post testing activities.
• Completing all laboratory documentation in a timely and accurate manner.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.
• Receipt and processing of drug substance and drug product samples.
• Adherence to and improvement upon lean lab and 6S practices.
• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Manager.

Preferred Experience:

• A minimum of a Level 8 degree in Microbiology or related discipline.
• At least 2 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
• Applicants should have relevant experience working in a cleanroom environment using aseptic techniques, and experience working with isolators is advantageous.
• Experience in HPLC and UV Spectrophotometry is desirable but not essential.
• Experience using MODA, Empower, CIMS, LIMS, LES and Veeva Vault is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.

Note:

• This candidate may be required to work a shift pattern.
• Due to the nature of the business additional duties may be assigned from time to time.
• All applicants must be eligible to work in Ireland.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

Apply Now