Quality Assurance Specialist

  • Contractor
  • Full-Time
  • Detroit, MI
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
  • Posted 2 years ago – Accepting applications
Job Detail
  • Offerd Salary $ 35 - $ 45
  • Required Position 2-4 hires
  • Experience 0-3 Years Required
Job Description

Job Opening for Quality Assurance Specialist - Open Lab Experience is a MUST, Detroit, MI
We are currently working on below mentioned job opening i., e. Job Opening for Quality Assurance Specialist - Open Lab Experience is a MUST, Detroit, MI. Please let me know if you are interested in applying for the same.

knowledge of OpenLab is a must
- create custom reports (for calculations) in OpenLab
- create project folders in OpenLab and set permissions
- data review in OpenLab
- strong knowledge of lab deviations, OOS investigations, root cause analysis, CAPAs
- knowledge of stability study programs, environmental chambers
- review historical lab raw data, deviations and OOS reports, identify if there are any gaps and update the reports
- write risk assessments reports, if gaps are identified during historical QC data review
- write and/or update QC/Analytical SOPs (specifically, OOS, stability, data review procedures)
- strong knowledge of data integrity
- working knowledge of QC lab equipment (HPLC, GC), Trackwise, Master control
- support other QC improvement initiatives (composite testing) and SOP revisions

Job Requirement

Job Opening for Quality Assurance Specialist - Open Lab Experience is a MUST, Detroit, MI
We are currently working on below mentioned job opening i., e. Job Opening for Quality Assurance Specialist - Open Lab Experience is a MUST, Detroit, MI. Please let me know if you are interested in applying for the same.

knowledge of OpenLab is a must
- create custom reports (for calculations) in OpenLab
- create project folders in OpenLab and set permissions
- data review in OpenLab
- strong knowledge of lab deviations, OOS investigations, root cause analysis, CAPAs
- knowledge of stability study programs, environmental chambers
- review historical lab raw data, deviations and OOS reports, identify if there are any gaps and update the reports
- write risk assessments reports, if gaps are identified during historical QC data review
- write and/or update QC/Analytical SOPs (specifically, OOS, stability, data review procedures)
- strong knowledge of data integrity
- working knowledge of QC lab equipment (HPLC, GC), Trackwise, Master control
- support other QC improvement initiatives (composite testing) and SOP revisions

Required skills