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Abbott Quality Specialist in Shanghai, China

主要工作职责 Key Responsibilities : ( 概括关键职责、每项职责所要达成的结果 / primary deliverables of roles)


Fully understand related quality regulation, company SOP and manufacturing process. To guide and supervise others to follow these SOPs.


Review the batch related production records and quality control records, ensure that the detailed reviews have been completed correctly and any deviations are closed and documented appropriately.


Hands-on management, finish the daily inspection for manufacturing, QC testing, material delivery and etc.. For the non-conforming issues and quality risk found during the inspection, raise solving protocols if possible and report to supervisor ASAP.


Assist supervisor and lead related dept. to finish non-conformance or complaint investigation. Conduct trending analysis for non-conformance and complaint on a regular basis and follow up the action implementation.


Non-conforming handling and work closely with relevant departments to follow up the all the non-conforming issues and CAPA related to products and raw materials from routine operation, Gemba walk, internal audit, external audit, supplier audit and customer complaint, etc.. Assure that the investigation has been performed thoroughly and the corrective and preventive actions are appropriate and comply with relevant procedures and regulations.


Analyze problems met in operation and propose preliminary solutions.


Ensure the updating of SOP & batch documentation when it is required due to for examples change control, validation activities, projects, SOP updating. Responsible for coordinating the approval of LCCR and packaging information specification.

SAP系统中Master Data及BOM的维护。

Maintain Master Data and BOM in SAP system


Undertake other tasks that assigned by QA Team Leader.

任职条件 Qualifications : ( 该职位任职者所需具备的成功要素 / Key success factors the job holder should have)

  • 文化程度Education:


Bachelor’s degree or above (biology, medicine, chemical industry or electronics related specialty).

  • 任职经验Working Experience:


12 years or above of quality department working experience in pharmaceutical/medical device/in-vitro diagnostics company. Familiar with the production process, be able to draft quality system documentation and production process procedure.

  • 专业知识/技能Professional Knowledge/Skill:


Familiar with quality system requirements of GMP, ISO, FDA and related regulatory.


ISO13485:2016 Internal Auditor certificate is preferred.

  • 计算机及外语水平Computer & Language Skill:


Good English skills both spoken and written.


Certain application capability of computer.

  • 能力要求Competency:


Have affinity, willing to take responsibility, good logical thinking, organize, coordinate, communication and presentation skill.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email