Quality Assurance Specialist
This role is an integral part of our Quality Assurance team, based out of our Ireland - Sligo site.
The key responsibilities for this position include:
* Qualification of new laboratory equipment as required.
* Performing GMP compliant and timely transfer of analytical methods.
* Generation of necessary documentation to support ongoing operation of the Quality Assurance laboratory, including procedures, work instructions, and protocols.
* Completing training of other analysts on test methods to be transferred.
* Performing sample analysis in accordance with standard operating procedures (SOPs).
* Coordinating the use of external test laboratories when required.
* Maintaining and importing laboratory reagents, media, and supplies.
* Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT results.
* Initiating and completing CAPAs and Change Controls in accordance with site procedures.
* Presenting analytical data/trend reports clearly and concisely to management.
* Providing out-of-hours On Call support for Critical Quality Impact Systems.
* Ad-hoc duties as required.
The ideal candidate will have a background in analytical method development, validation, and/or statistical quality control. They should have an understanding of GMP, ICH, and compendia regulations and guidance's. Excellent problem-solving skills, risk management, and decision-making are essential. The candidate should also have experience in laboratory-based aseptic techniques, excellent collaboration skills, and attention to detail.
Education and Experience:
A minimum of 3 years' experience in the biotechnology and/or pharmaceutical industry, with operational experience of quality laboratories and/or new product/assay introductions.
Demonstrated competency in bioassays, including polymerase chain reaction (qPCR and RT-PCR) and enzyme-linked immunosorbent assays (ELISA), is required. Experience in immunological assays such as viral titrations and cell-based bioassays is an advantage. Experience in analytical transfer programs and method development/validation is also desirable. Proficient in written and spoken English is essential.
Benefits:
We offer a competitive benefits package, which includes health insurance, retirement savings plan, and paid time off.
Equal Opportunities Employer:
We are an equal opportunities employer and welcome applications from all qualified candidates.
Job Requirements
* Strong analytical and problem-solving skills
* Excellent communication and interpersonal skills
* Ability to work independently and as part of a team
* Proficient in Microsoft Office and Google Suite
* Ability to maintain confidentiality and handle sensitive information
Interested candidates should submit their resume and cover letter for consideration.