15 часов назад
Analyst Quality Control (Contract)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Analyst Quality Control (Contract) (Pharmaceutical QC): Performing GMP-compliant laboratory testing and reviewing analytical data for vaccine manufacturing in Incheon with an accent on laboratory documentation, data integrity, and quality systems. Focus on investigating laboratory issues, managing LIMS and Empower activities, supporting equipment qualification and calibration, and handling CAPAs and change controls.
Location: Incheon, Songdo, Republic of Korea; onsite
Company
Johnson & Johnson MedTech, through Janssen Vaccines, develops healthcare and vaccine solutions. The role is fixed-term during a planned manufacturing-facility transition.
What you will do
- Perform QC laboratory testing in compliance with GMP, corporate requirements, and approved procedures.
- Review analytical data and test results and support laboratory investigations when issues occur.
- Prepare, revise, review, maintain, and archive GMP/GLP documentation, including test methods, worksheets, and procedures.
- Use and administer laboratory systems such as LIMS, MES, LES, and Empower.
- Manage laboratory equipment qualification, decommissioning, calibration, and maintenance activities.
- Coordinate non-conformances, CAPAs, change controls, audits, inspections, visitor support, and laboratory safety activities.
Requirements
- Bachelor’s degree in Chemistry, Chemical Engineering, Life Science, Pharmaceutical Engineering, or a related field.
- Fluency in written English and conversational spoken English is preferred.
- Ability to organize and prioritize workload and collaborate effectively with colleagues and external parties.
- Knowledge of Microsoft Office, including Outlook, Excel, Word, and PowerPoint.
- Knowledge of cGMP or GLP and relevant compendial requirements such as USP, EP, or JP is preferred.
- At least 3 years of experience, preferably in the pharmaceutical industry or a QC department.
Nice to have
- Experience with basic and advanced testing in a functional laboratory.
- Independent troubleshooting and basic root-cause analysis skills.
- Experience with quality systems documentation, data analysis, and quality control testing.
Culture & Benefits
- Fixed-term employment with Janssen Vaccines during the transition period.
- Employment governed by Janssen Vaccines’ processes, policies, programs, and benefit plans.
- Inclusive work environment focused on collaboration, individual dignity, and respect for diversity.
- Work in a regulated vaccine-manufacturing laboratory environment with a strong focus on safety, compliance, and data integrity.
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