Biotech Quality Assurance Specialist Position Available
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Join a leading international biotechnology company as a QA specialist in Dun Laoghaire, Dublin. This is an exciting opportunity to get experience in Ireland's premier aseptic manufacturing plant.
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The successful candidate will be responsible for overseeing the development and maintenance of site quality systems, including but not limited to documentation management, change control, deviation/capa processes, and oversight of applicable QMS systems.
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Key responsibilities include providing quality direction and input at change control and deviation review boards, assuming oversight of change control and deviation/capa records, and ensuring scope of record is clear and implementation activities are robust and timely.
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Additionally, the QA specialist will oversee and implement quality agreements relating to their area of responsibility, keep abreast of regulatory initiatives and new guidance/requirements, and communicate revised guidelines associated with Amgen quality systems.
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Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating standards and/or corporate policies & procedures. Oversight and management of quality risk management (qrm) processes and embedding qrm principles within the quality framework.
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Ownership, accountability, and provision of subject matter expertise for key quality systems, including change control, deviation/capa processes, and documentation management. Responsible for trending programs associated with deviation/capa, change control, complaints, periodic reviews, qrm, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
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In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
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Requirements include a university degree, preferably in an engineering or science-related discipline, relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
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Excellent written and verbal communication skills, experience working with dynamic cross-functional teams, and proven abilities in decision making. Strong organizational skills, including ability to follow assignments through to completion, demonstrated ability in problem solving, and experience in managing root cause analysis/deviation investigations.
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Detailed knowledge of applicable regulatory requirements and experience with regulatory inspections. Experience working in aseptic operations, protein formulation, vial and syringe filling.
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Benefits include a contract role with an hourly rate of €25-€33 per hour, minimum 12-month contract, fully onsite work, on-call rotation every 8 weeks, OT/DT eligibility, and shift rate of 35%.