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Analyst Chemistry QC
Requisition ID: 1805627919W
Routine testing and reviewing work: Perform testing for raw materials, final products, stability samples, bulk samples and complaint samples within required testing cycle time. Review raw data in time and make sure that the record meets GMP and GLP compliance requirements.
Assist Supervisor or Senior Analyst to perform the OOS/ER investigation to find out the root cause. Complete the related action plan in the Change Request with guidance of Supervisor or Senior Analyst.
Write compliant SOP/WI according to the actual operation process and guide employees.
Method qualification: Fulfill the new method qualification according to approved protocols or procedure.
Technical support: Provide relevant technical support about chemical analysis.
Regulation compliance: Comply with the requirements of ISO13485, GMP, QSR820, 21CFRPart 211 and company regulation.
Others: Perform other working tasks, such as the urgent task of the team.
EDUCATION ADN EXPERIENCE
Pharmacy, pharmaceutical analysis, analytical chemistry or related major, junior college degree or above.
At least two years related experience in the chemical lab of medicinal or medical devices international company and command knowledge of GMP and GLP, or the graduating student from famous university with Bachelor or Master Degree.
ESSENTIAL SKILLS AND ABILITIES
Good communication and interpersonal skills, Integrity and ethics and detail oriented.
Ability to read and write English preferred.
- 能够娴熟的使用Windows及office办公软件Computer operation skill is well, such as practice in Excel, Word and PowerPoint.
AMO (Hangzhou) Co., Ltd. (7077)