21 час назад
QC Microbiology Analyst
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Microbiology Analyst (Pharmaceutical Quality Control): Conducting laboratory audits, maintaining compliant facilities and equipment, and supporting product sample analysis with an accent on regulatory readiness, instrument verification, and quality system procedures. Focus on leading continuous improvement projects within drug product manufacturing, identifying compliance discrepancies, and implementing corrective actions.
Location: Melbourne, Victoria, Australia; on-premise
Company
develops and manufactures pharmaceutical products with a strong focus on product quality, regulatory compliance, and patient safety.
What you will do
- Conduct internal audits of R&D and quality laboratories to ensure readiness for regulatory inspections.
- Monitor compliance with pharmaceutical manufacturing policies, procedures, and regulatory requirements; identify discrepancies and recommend corrective actions.
- Maintain laboratory areas, equipment, facilities, reagents, and reference standards in a clean, orderly, and operational state.
- Verify and calibrate instruments and equipment supporting chemical and physical sample analyses for annual product reviews.
- Develop working practices and guidelines for quality system Standard Operating Procedures and manage the review and approval of Building Management System alarms.
- Lead the Continuous Improvement process for Integrated Manufacturing Excellence within the Drug Product unit.
Requirements
- BA/BS degree with any years of experience, or an Associate's degree with 4+ years of experience, or a high school diploma or equivalent with 6+ years of relevant experience.
- Solid understanding of common laboratory databases.
- Familiarity with regulatory compliance requirements for pharmaceutical manufacturing.
- Proficiency in using quality system Standard Operating Procedures.
- Ability to work independently and collaboratively.
Nice to have
- Experience in a pharmaceutical microbiology laboratory.
- Strong problem-solving skills and the ability to manage multiple tasks and projects.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, including responsible AI, risk management, and ethical-use practices.
Culture & Benefits
- Paid parental leave and options to purchase additional leave.
- Health and wellness applications, flu vaccinations, and skin checks.
- Career growth, learning, recognition, and rewards programs.
- Paid volunteer days and life insurance benefits.
- Salary packaging and novated lease options.
- Opportunities to participate in diversity, equity, and inclusion colleague resource groups and workstreams.
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