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Quality Assurance specialist (QMS)

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 Chemists/Specialists, validation project coordinators, laboratory management, and the Global Technical Support (GTS) SME.

Primary responsibilities are reviewing Physical and Retention protocols and reports, laboratory records and raw data as well as identifying opportunities for and the implementation of continuous improvement as directed by the BVS Quality Manager and/or Global Head of Quality for BVS. Additional responsibilities include issuance and accountability of test worksheets/lab records, conducting self-inspections and supplier audits, supporting the maintenance and integration activities related to the laboratory’s Quality Systems as directed by the BVS Quality Manager including but not limited to supporting the closure of data integrity gaps, performing routine inspection of laboratory records to ensure audit readiness, handling deviations, CAPA and change controls assignments and reviewing instrument/equipment/software qualification protocols and reports. The position’s main responsibilities include:

  • Quality Reviewer for Test Protocols and Reports

           * Bubble Point Testing

          * Preservative Binding Studies

          * Diffusion ratio and Rate Determination

          * Compatibility Testing

          * Compatibility Certification

          * Environmental and Water Monitoring records.

          * Bacterial retention study as needed

 

  • Worksheet issuance -Worksheet issuance for all the study
  • Document controller(Creation and Modification of SOP’s when required. Periodic Effectiveness of Validity review.)
  • Deviations and CAPAs( (process and tool for non-conformance, OOS, etc. in Trackwise).
  • Managing/Maintaining Supplier Quality Management Program.
  • Review of calibration, PM and validation reports, Environmental and Water Monitoring records.
  • Validation Master Plan execution as need.
  • Manually record training when needed adhere to the learning plans. Periodically run training completeness as need.
  • Monthly review of Lab logs.
  • QMS improvement and GAP closure.
  • Monthly Sample Discard list verification.
  • GAGE Trak Usage for calibration program.
  • Lead Test Failure Investigations(RCA practice) - give test failure investigations highest priority due to potential impact/risks/questions to the business, customers and authorities, use improved CAPA workflow.
  • Supporting to Customer Audits, ISO audits, self-inspection audits
  • Oversee execution to schedule to ensure equipment instruments, software and assays are
    qualified/available for use and fit for purpose.
  • Visual management – KPI/KQI/Metrics (balance scorecards) providing data.
  • Monthly barometer input/EES.
  • Actively demonstrate Merck values & behaviors.
  • GAGEtrak Usage for calibration program.
  • In collaboration with worldwide BioReliance Lab Quality leaders, actively participate in the global Quality policy and tools harmonization & implementation programs.
  • Drive quality culture change at the local level.
  • Follow all safety training. Support EHS and OSHA implementation as need.

 

 

 

Who You Are:

Excellent communication is necessary for keeping the lab team, VPM team, lab managers updated on the status of the test

  • Knowledge of aseptic operation for microbiology
  • Expertise of good laboratory practices
  • Strong organizational and time management skills
  • Demonstrate troubleshooting competencies.
  • Excellent understanding of SOPs & protocols.
  • Expertise in microbiology or physical and chemical domains
  • Expertise for regulation related to our services, data integrity and Good Documentation Practice
  • Demonstrate ability to adapt to change (process, tools, organization …)
  • Team spirit and respectful behavior
  • Positive attitude and mindset.
Job Requisition ID:  203581
Location:  Shanghai - all
Career Level:  B - Recent University Graduate(<1 year of experien
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: Microbiology, Quality Manager, QA, Quality Assurance, Quality, Science, Technology

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