QC Supervisor at Thermo Fisher Scientific Inc Japan
Australia Capital Territory, Australian Capital Territory, Australia - Full Time
Start Date
Immediate
Expiry Date
06 Jan, 27
60000.0
Posted On
22 Oct, 26
Experience
14 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
Yes
Skills
Description
REQUIREMENTS:
- Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in pharmaceutical/biotech quality control, with 2+ years in a leadership role
- Preferred Fields of Study: Chemistry, Biology, Biochemistry, Microbiology or related scientific field
- Additional certifications in quality systems, regulatory compliance, or project management beneficial
- Strong knowledge of cGMP, FDA regulations, ICH guidelines and quality systems
- Experience with analytical testing methods and instrumentation (HPLC, GC, dissolution testing, etc.)
- Proven ability to lead and develop teams while fostering a quality-focused culture
- Strong technical writing skills for SOPs, investigations, and regulatory documentation
- Experience managing laboratory operations, including scheduling, resource planning and process improvements
- Proficiency with laboratory information management systems (LIMS) and quality management software
- Excellent project management and organizational skills
- Strong interpersonal and communication abilities to interact with all levels of the organization
- Experience supporting regulatory audits and inspections
- Demonstrated problem-solving skills and ability to lead investigations
- Working knowledge of data integrity principles and documentation requirements
- Ability to prioritize multiple responsibilities while maintaining high quality standards
- Experience with risk assessment and root cause analysis
- Proficiency with Microsoft Office applications
- Flexibility to adjust schedules as needed to support manufacturing operations
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