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Quality Assurance specialist (E&L)

Your Role:

The Quality Assurance Specialist will report directly to the local BioReliance Validation Services (BVS) Quality Manager, and will work directly with other BVS Quality Assurance staff, validation project coordinators, laboratory management, and the Global Support (GS) Extractables and Leachables (E&L) SME. Primary responsibilities are providing support to the E&L laboratory by reviewing test protocols and reports, laboratory records, raw data, computerized system and instrument qualification protocols and reports, and standard operating procedures. Additional responsibilities include oversight and approval of change controls, deviations, root cause investigations and CAPAs, issuance and accountability of worksheets and lab records, conducting self-inspection audits, leading continuous improvement initiatives and other duties as needed [RD1] under the direct supervision of the BVS Quality Manager.


Who You Are:

  • Bachelor of Science (BS) degree and a minimum 3 years of experience working in a regulated environment (e.g. GxP) in a Quality role, master degree preferred
  • Working knowledge of analytical methods development, validation and transfer
  • Working knowledge of analytical instrumentation including HPLC, FTIR, GCMS and LC-Q-TOF
  • Working knowledge of Waters Empower, Masshunter and TrackWise software preferred
  • Experience leading test failure (i.e. OOS) investigations, deviations and CAPAs
  • Understanding of risk management principles
  • Proficient with Microsoft Word and Excel
  • Excellent written and oral communication skills
  • Strong organizational and time management skills
  • Ability to read and review documents in both English and Chinese
  • Comfortable working in a fast pace environment
  • Demonstrate ability to adapt to change (process, tools, organization …)
  • Team spirit and respectful behavior
  • Positive attitude and mindset
Job Requisition ID:  203586
Location:  Shanghai - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Quality Assurance, QA, Laboratory, Inspector, Quality, Technology, Science

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