обновлено 14 часов назад
QC Specialist Separations
52 400 - 82 915€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Specialist Separations (Quality Control/Pharmaceutical Manufacturing): Supporting compliant laboratory testing, analytical equipment qualification, method transfers, and investigations in a regulated pharmaceutical manufacturing environment with an accent on HPLC, spectrophotometry, nephelometry, and Total Organic Carbon systems. Focus on coordinating complex QC projects, reviewing data and quality investigations, and ensuring GMP-compliant execution across laboratory operations.
Location: Ringaskiddy, Cork, Ireland; hybrid work
Base pay: €52,400–€82,915 annually
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions designed to improve patient outcomes.
What you will do
- Provide technical support for day-to-day Quality Control testing operations in a regulated pharmaceutical manufacturing environment.
- Coordinate analytical equipment qualification and testing activities for HPLC, spectrophotometry, nephelometry, and Total Organic Carbon systems.
- Plan and coordinate analytical method transfers for New Molecular Entities and support sampling and testing for raw materials, utilities, in-process samples, bulk, and finished products.
- Review and approve laboratory data, investigations, deviations, CAPAs, and Change Controls.
- Plan and oversee laboratory projects, process improvements, lean initiatives, and LIMS scheduling activities.
- Train laboratory personnel, present technical information to internal stakeholders and regulatory inspectors, and collaborate across departments to maintain GMP compliance.
Requirements
- At least 3 years of experience in the pharmaceutical industry.
- Previous supervisory experience in an IMB/FDA-regulated facility.
- Knowledge of FDA and EMA requirements applicable to biologics and/or pharmaceuticals.
- Technical knowledge of analytical techniques and laboratory equipment in chemistry, biochemistry, and/or microbiology.
- Experience with analytical testing, equipment qualification, and analytical method transfer activities.
- Strong collaboration, critical thinking, problem-solving, communication, coaching, and accountability skills.
Nice to have
- Experience with ISO 9001, quality auditing, quality systems documentation, and compliance management.
- Awareness of AI concepts, responsible AI practices, and effective prompting techniques.
Culture & Benefits
- Collaborative and inclusive environment focused on learning, innovation, and professional development.
- Exposure to advanced analytical technologies and critical quality activities supporting patient-focused products.
- Annual bonus based on pay grade, location, and performance.
- Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement, financial, physical and mental health programs, recognition awards, and insurance plans subject to eligibility.
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