- 経験
- 2～3歳
- 給料
- —
- 求人情報
- 1
- 投稿済み
- 9時間前
- 作業モード
- 在任中
- 教育
- 学士号
- 再開する
- 応募必須
勤務地
仕事内容
About the Role and Company
Join a rapidly growing, supportive team at a strategic manufacturing site specializing in the analysis of world-class biologics and vaccines. Working in a state-of-the-art Quality Operations laboratory, you will contribute significantly to a facility that underpins global pharmaceutical supply chains.
Reporting to the Quality Control Manager, you will support the expansion of the laboratory by leading analytical method transfers, validations, and performing commercial release testing.
Key Responsibilities
- Conduct sophisticated analytical testing, including techniques such as HPLC (including HIC, CE, IEX, HP-SEC), Capillary Electrophoresis, ELISA, Cell-Based Assays, Cell Culture, and other pharmacopoeial test methods.
- Perform sterility tests and routine laboratory tasks in strict adherence to GMP and GLP standards.
- Use Laboratory Information Management Systems (LIMS) for sample tracking and data handling.
- Lead and assist with analytical method transfers and validations for new and current drug products.
- Ensure compliance with company safety protocols, international regulatory standards, and cGMP/cGLP.
- Review peer testing documentation rigorously to maintain data integrity and consistently achieve "Right First Time" KPIs.
- Complete and process analytical data promptly and accurately.
- Lead and support investigations regarding Out of Specification (OOS) results.
- Promote a culture prioritizing safety and compliance within the workplace.
- Apply root cause analysis methodologies (e.g., FMEA, Fishbone diagrams, 5 Whys) to address system or equipment problems.
- Participate actively in daily QC Tier 1 meetings, discussing test progress, scheduling, and deviations.
- Develop, update, and implement SOPs, technical procedures, and training documents.
- Provide expertise and support during both internal and external regulatory inspections.
Required Qualifications and Skills
- Bachelor’s degree or higher in Analytical Chemistry, Biochemistry, or a closely related scientific field.
- 2 to 3 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical laboratory environment.
- Practical experience with HPLC instrumentation and software or in cell-based assay techniques is highly valued.
- Strong knowledge of cGMP, GLP, Quality Management Systems, and laboratory data integrity.
Site and Culture
The facility is a premier commercial filling site dedicated to the launch and global distribution of vaccines, biologics, and small-molecule drugs. Featuring cutting-edge production and analytical laboratory technologies, it is recognized as a key employer in the South East region and maintains strong collaborative ties with regional universities.
An inclusive and diverse workplace culture is cultivated, encouraging respectful challenge of ideas and teamwork to address complex challenges. The employer is an equal opportunity provider and welcomes requests for reasonable accommodations throughout the recruitment process.
Additional Information
- Shift Patterns: Several options are available to suit various scheduling needs.
- Travel: Occasional travel may be necessary for training purposes.