Job Description
Job Purpose
Responsible for conducting inspections of raw materials, intermediate products, finished products, and stability samples in accordance with current regulations, quality standards, and operating procedures, ensuring accurate and reliable test data to support product release and continuous quality system improvement.
Key Responsibilities
- Testing and Analysis
- Complete testing of raw materials, auxiliary materials, intermediate products, finished products, and stability samples according to inspection procedures.
- Accurately record, organize, and review raw experimental data to ensure results are authentic, complete, and traceable.
- Issue inspection results in a timely manner and complete relevant records as required.
- Laboratory Management
- Responsible for the daily use, inspection, maintenance, and cleaning of laboratory instruments and equipment.
- Assist with equipment qualification, calibration, and validation activities.
- Maintain laboratory 5S management requirements and safe operations.
- Quality System
- Strictly comply with GMP, CVP, and Data Integrity (ALCOA+) requirements.
- Participate in quality activities such as deviations, OOS/OOT, CAPA, and change management.
- Participate in method validation, method verification, and laboratory continuous improvement projects.
- Cooperate with internal audits, customer audits, and regulatory inspections.
- Team Collaboration
- Maintain good communication with production, Quality Assurance (QA), technology transfer, and other departments.
- Complete training as required and continuously improve professional skills.
- Complete other tasks assigned by the department manager.
Qualifications
Education Background
- Bachelor's degree or above.
- Majors in biotechnology, bioengineering, veterinary medicine, pharmacy, microbiology, immunology, chemical analysis, or related fields.
Work Experience
- 5+ years of QC work experience in the pharmaceutical, biological products, or vaccine industries is preferred.
Professional Skills
- Familiar with basic laboratory operations and testing techniques.
- Experience with cell culture, ELISA, viral titer testing, etc., is preferred.
- Familiarity with GMP and other regulatory requirements is preferred.
Required Skills:
Adaptability, Analytical Instrumentation, Analytical Method Development, Communication, Continuous Improvement, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment
Preferred Skills:
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/2/2026
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