Laboratory Instrument Administrator

Job Responsibilities

1. Responsible for drafting, revising, and reviewing management and operation documents related to laboratory analytical instruments, and regularly inspecting and assessing to ensure the documents are suitable for use.
2. Manage the analytical instruments in the laboratory and coordinate the use of instruments with the inspection team.
3. Formulate or assist in formulating annual plans for the maintenance, calibration, and qualification/validation of laboratory instruments, and implement according to the plan to ensure the normal use of the instruments.
4. Participate in handling deviations and changes related to analytical instruments.
5. Coordinate the testing team's requirements for the use of analytical instruments, draft or assist in drafting the corresponding URS (User Requirement Specification).
6. Participate in the development of grading, permissions, and strategies for laboratory analytical instruments and their software.
7. Participate in the qualification/validation implementation of analytical instruments and their software, draft or assist in drafting the corresponding qualification/validation plans and reports, including instrument qualification, CSV (Computer System Validation), etc.
8. Communicate with suppliers of analytical instruments, coordinate the procurement, acceptance, installation, repair, and replacement/scrapping of instruments.
9. Manage consumables for laboratory analytical instruments.
10. Maintain laboratory layout and facilities, promptly report and arrange the handling of any abnormal situations.
11. Participate in company self-inspections and official audits, answer questions related to analytical instruments.
12. Summarize various incidents involving laboratory analytical instruments, conduct regular reviews and evaluations, and report them.
13. Engage in cross-departmental communication with QA validation team, equipment engineering department, and IT.
14. Complete other tasks assigned by the superior.

Job Requirements

1. Associate degree or above in chemistry, biology, pharmacy, or related fields.
2. Understand basic principles of testing laboratories; familiar with GMP regulations; familiar with QC instrument operation; familiar with domestic and international regulations on computerized systems.
3. Good English reading skills, proficient in computer operation.
4. More than 2 years of work experience in pharmaceutical companies and at least 1 year of management experience.

HR Email: hr@biotech-pack.com (If interested, please contact us through this email or directly submit your resume.)