Full-timeEstimated: $76,000 - $110,000 a year
- Quality Assurance
- Root Cause Analysis
- Bachelor's Degree
Full Job Description
As part of the Quality Systems shared services group this role will provide quality oversight and expertise for the qualification, verification, and validation of GxP equipment systems and processes. Working with R&D, Clinical, Development and/or Manufacturing functional leads, this role will ensure activities involving the commissioning, qualification, verification and/or validation of systems and processes are performed via Seres internal controls and meet regulatory requirements.
What You’ll Do
- QA oversight of the Seres Validation Program efforts including GxP test methods, facilities, utilities, equipment, process, and computerized systems.
- Assist business partners with the development of validation plans and protocols
- Work with QA partners to ensure execution was performed
- Identify key areas of improvement supporting GxP validation efforts
- Support business partners in making sure that the defined methodology and approach for supporting qualification validation initiatives are performed with scientific, regulatory compliance and statistical validity (as applicable)
- Support projects teams as the Quality SME for review/approval of deliverables associated with equipment systems and processes. This includes the tech transfer, qualification, verification, validation and reverification activities
- Provide training to business partners to educate as needed to support validation, qualification and verification activities
- Ensure that there is adequate rationale defined for the closure of generated non-conformances, discrepancies and deviations associated with verification/validation execution efforts.
- Assist and support QA Operations in the evaluation of risk assessments related to validated state of equipment and processes.
- necessary review and approval of QA change management activities and reviews on changes to verification/ qualification and requalification applicable GxP procedures. General QA support for all functions and as needed for outside vendors. for CMC, Donor Operations and Clinical Operations.
What You’ll Bring
- Bachelor’s degree in life sciences, or engineering with 8 to 10 years of experience in the biotech/or pharmaceutical industries
- Experience supporting equipment, instrument and system qualification activities in R&D, Clinical or Manufacturing commercial organizations.
- Experience in supporting cleaning and process validation campaigns
- Experience supporting Test Method Verification/Validation activities (preferred)
- Support change controls, deviations, investigations root cause analysis and CAPAs as required
- Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
- Advanced knowledge and demonstrated experience using Industry International Standards and Guides (USP/ EP/ ISO/ IEEE/ ASTM/ ISPE/ PDA) and applicable GXP FDA, Canada, European, ICH regulations & guidelines
Job Type: Full-time
- Quality Assurance: 8 years (Required)
This Job Is Ideal for Someone Who Is:
- Dependable -- more reliable than spontaneous
- Adaptable/flexible -- enjoys doing work that requires frequent shifts in direction
- Detail-oriented -- would rather focus on the details of work than the bigger picture
- Achievement-oriented -- enjoys taking on challenges, even if they might fail