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Principal Recruitment Consultant in Quality Control (Contract & Permanent)Biochemistry, Chemistry & Microbiology
I am recruiting for a QC Microbiology Analyst to join a leading biopharmaceutical company located in North Dublin. The analyst will be responsible for supporting Drug Substance and Drug Product site activities related to Bioburden and Endotoxin in-process testing and sample processing.
Key Duties and Responsibilities
* Carrying out In-Process testing of critical lot related samples to support Manufacturing activities.
* Performing Bioburden testing on Utility samples, Drug Substance and Raw Materials within required hold times.
* Performing Bacterial Endotoxin Testing on Utility samples, Drug Substance and Drug Product within required hold times
* Performing Growth Promotion testing of media lots entering the laboratory.
* Carrying out identifications of Microorganisms isolated post testing activities.
* Carrying out the Minute Mouse Virus by PCR for in-process samples.
* Performing compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
* 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.
* 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.
Qualifications and Experience
* The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
* At least 1 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
* A strong background in Microbiology and aseptic technique is desirable but not essential.
* Sterility experience is desirable but not essential.
* Experience in Bioburden and Endotoxin testing is desirable but not essential.
* Experience using MODA, 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.
Seniority level
* Associate
Employment type
* Contract
Job function
* Science
Industries
* Pharmaceutical Manufacturing
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