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| » Job Details | Go Back |
| Job Title: Sr Quality Assurance Specialist |
| Description |
| Job Description:
• Independently participate in cross-functional teams providing GCP/GLP guidance and risked based options during meetings
• Review of study documents (e.g. protocols, system validation reports, final study reports.) Checks document for consistency and acceptable standards and practices.
• Solid understanding and application of Development SOPs, departmental controlled documents and GCP and regulations
• "Go to" person - technical excellence in all Development QA programs (Procedures, Assessments, Cross functional Teams)
• Independently collaborates and facilitates meetings with specific functional groups providing guidance on SOPs (i.e. content, quality, SOP lifecycle), identifying gaps, addressing any documentation need, conducting process mapping sessions and impacts the process map/flow and suggests process improvements. Take initiation in completing the improvement.
• Advanced knowledge of Electronic Document Management System (EDMS) in performing all EDMS activities related to SOPs.
• Independently represents DevQA on Development initiatives (cross functional teams) applying solid knowledge of internal processes, procedures and regulations.
• Develops appropriate assessment tools; plans, schedules, and conducts assessments; reports, trends, and analyzes data findings
• Provides support during regulatory inspections and internal functional group audits. Advanced understanding of documents governing the inspection readiness.
• Conduct brown bags sessions. Identify and development future brown bag topics in consultation with the management team.
• Effectively coach junior staff in the areas of regulations and documentation.
• Takes initiative to identify areas for process improvement and engage in assuming new responsibilities
• System Review/Validation
• Solid understanding and application of the SDLC methodology adopted by the Development organization
• Application of industry guidance and best practices regarding the validation and documentation of computer systems (e.g., GAMP, Computer Systems Used in Clinical Investigations).
• Expertise in the interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 58, 211, 312) used in GxP environment for US and ex-US.
• Review SDLC documents used in the validation of GCP/GLP systems (includes IVRS and EDC user acceptance tests)
• Conducts Good Documentation Practice training for IVRS and EDC User Acceptance testing
• Performs review of SAS data used in Clinical Study Reports and discuss issues found with DevQA review lead or Statistical Programmer analyst.
• Performs assessment of computer systems used in Development. Identify impact of intended system use to data integrity and propose procedural controls to mitigate risks.
• Collaborates with functional groups to identify computer systems compliance issues pertaining to regulated systems used within Development as well as systems used at the investigator sites. Provides risk-based recommendation and be able to influence business process owner to take action for mitigating risks.
• Participates in the selection process for vendor supplied systems used in GxP by attending vendor presentations and providing feedback to the system owner
Job Qualifications:
• 10 years of GCP/GLP experience in pharmaceutical or biotechnology industry; with at least 7 out of 10 years in QA arena, or equivalent transferable experience
• Advanced understanding and first hand knowledge of drug development, study design, data and trials management systems, procedures and documentation practices.
• Expert - level knowledge of GCP/GLP regulations
• Bachelors degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience or equivalent transferable experience
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| Details |
| Job Ref: |
LC-0027 |
| Hours: |
Full Time |
| Location: |
San Francisco, California, United States |
| Working Term: |
Permanent |
| Salary: |
$100,000 to $110,000 |
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