Overview
QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory.
Start Date - ASAP
Location - Dublin, Ireland
Duration - 11 Months (FTC)
Responsibilities
* Perform and carry out a variety of routine analytical techniques, including but not limited to HPLC, Compendials, UV, Raw Materials, DNA PCR, and Bioassay ELISA testing in compliance with GMP requirements.
* Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
* Support the laboratory testing schedule to achieve an efficient QC system.
* Receive and manage samples that come into the lab for stability, in-process and release testing.
* Reagent preparation, cleaning, and routine equipment maintenance.
* Maintain good housekeeping and hygiene within the laboratory.
* Calibrate and maintain all designated laboratory instruments.
* Participate in risk assessments, inspections, audits, incident investigations, and implement and follow up on corrective/preventative measures.
* Ensure training is current for all job functions performed.
* Order, stock, and receive laboratory supplies.
* Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
* Ensure that cGMP standards are always maintained.
* Promote and participate in the implementation and maintenance of the relevant safety programs.
Experience, Knowledge & Skills
* 1 - 5 years of laboratory testing experience in the pharmaceutical industry.
* Relevant experience and skill set in their area of expertise that add value to the business; ideally in a manufacturing, preferably in a GMP setting.
* Experience and critical skills in the area of expertise that add value to the business; ideally, bioassay and DNA tests.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Knowledge of cGMP & Laboratory Quality Systems.
* Effective communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
Qualifications & Education
Qualification in Science/Chemical Engineering/Biological Engineering.
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance, Product Management, and Science
Industries
* Pharmaceutical Manufacturing
* Biotechnology Research
* Medical Equipment Manufacturing
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