Mandakini Bhattacherjee Email & Phone Number

Hayward, California, United States

Site Internal Quality Audit Program Lead:● Develops the annual internal quality audit schedule ● Leading audit teams to conduct internal quality audits● Assigns audits to lead and co auditors● Managing audit records, audit actions and audit metrics● Auditors training and qualification● Responsible for maintaining internal quality audit documents● Mentor new auditorsQuality Ops QMS and Compliance Project Lead:● Core and extended project QA team member for New Product Introduction (NPIs) and site- specific projects for on-the-market products focusing on Quality Management System and Compliance NPIs: NovaSeq 6000Dx, NovaSeq X series● Conduct gap assessments of current processes for projects

Hayward, California, United States

Site Internal Quality Audit Program LeadNSF certified - Quality Management Systems Certified Lead Auditor (ISO 13485:2016 and MDSAP requirements)

Pleasanton

● Managing a team responsible for Quality Engineering, product release, and generation of Certificates of Analysis● Mentoring, training, and prioritizing daily activities in a fast-paced make-to-order manufacturing environment● Generation of actionable metrics driving improvement activities ● Identify and escalate quality related issues; propose and implement solutions ● Collaborate with New Product Introduction (NPI) teams and Product Management to develop certificate of analysis templates and batch record requirements ● Demonstrated effective performance management skills (writing and delivering employee reviews, identifying staff strengths and growth opportunities) and planning employee compensation. Improved staff performance through coaching, performance improvement plans, and cross training.● Management and subject matter expert for all product holds, recalls and customer notifications related to customer complaints as per ISO 13485 and QSR 21 CFR Part 820.198● Certified Lead Internal Auditor (ISO 13485/9001)

Complaint analysis, management and resolution● Evaluate complaints to identify the need for escalation/CAPA. Document justifications for all complaint closures ● Drive and document investigations for escalated technical complaints; collaborate with Product Managers, Manufacturing Sciences and Manufacturing● Generate complaint metrics and reports; responsible for all complaint handling SOPs and work instructionsPost Market Surveillance ● Monitor and manage PMS data worldwide for distributed products ● Generate PMS metrics and reports for identifying trends Product Holds, Recalls and Customer Notification ● Management and subject matter expert for all product holds, recalls and customer notifications related to customer complaints. Requires extensive collaboration with Product Management, Legal, Regulatory Affairs, Manufacturing Sciences, Manufacturing, and Supply Chain.● Certified Lead Internal Auditor (ISO 13485/9001)● Quality Engineering support for both custom and inventoried manufacturing, and distribution ● Review and approval for planned/unplanned deviations, CAPAs and NCMs. Close collaboration with manufacturing and distribution staff to assess impact, drive appropriate investigations and develop effective corrective action plans● Certificate of Analysis program management● Generate, review and approve COAs for customers under tight timelines ● Driving revision/creation of COA templates

• Responsible for identifying Test Data, developing Test Scenarios and Test Cases for various Manual Testing Projects.• Responsible for manual testing, documenting defects and retesting in Quality Center.• Uploading Test data in Quality Center for testing.• Executing test scripts in Toad for Oracle as part of manual testing.• Responsible for updating Project Metrics in QACC Key Initiatives Confluence Wiki. • Publishing new QA project data on QACC Wiki by creating new information pages.• Responsible for writing and publishing QA Project Success Stories.

1. Extracted, validated, analyzed, cleaned and combined multiple product replacement data from SAP using Business Objects and FileMaker Pro and presented my analysis to the Quality Management Team via various Monthly Quality Replacement Reports and Graphs. 2. Designed and created a reporting template in Excel that automated large volume of customer complaint data into graphs.3. Conceptualized and gathered data requirements for designing Product Shipped Quantity database in MS-Access that mapped shipped quantity with Oligo and Assay part numbers aligned by product groups. Responsible for maintaining and updating the database with new released part numbers and generating Shipped Quantity Ad hoc Reports. 4. Processed Change Request Orders for new part numbers using SAP and Lotus Notes.5. Created Certificate of Analysis for different product lines for global customers.6. Assisted the QA team in defining of Standard Operating Procedures for Certificate of Analysis. 7. Responsible for testing Manufacturing data after migration and integration in Access database.

> Analyzed product test results on various product complaints and provided reports to the customers and the manufacturing plants.> Validated and analyzed all customer complaint and claims data and generating monthly reports in Excel for the management.> Managed consumer complaint database maintained in MS- Access.> Coordinated product claim cases with the claims department of the company and traced the product complaint and claim cases. > Coordinated marketing projects for new product launches and customer surveys.

> Assisted the HR department in organizing and maintenance of the Learning Resources Library.> Coordinated New Employee Orientation, Public Speaking and Presentations, Respect at Workplace, Interest Based Negotiations, Providing Excellent Customer Service and Safety in Workplace workshops.> As a member of the special project team undertaking the Optical Imaging project for Payroll and Benefits, identified and categorized filing system and provided input to the IT department. > Assisted applicants to match job requirements with their skills, received job orders from employers, updated applicant data and performed file-based searches.> Conceptualized and created a Microsoft Access Database to acquire, maintain and query applicant data.

> Managing employee timesheets, staff salaries, managing bills, petty cash and office inventory.> Coordinating and facilitating client interactions in multiple locations.> Managing the upkeep and security of all transit locations.> Managed environmental, health and safety programs of the employees in the transit locations.

Mba, Technology Management

MBA, Technology Management

Ma, Political Sc.

Masters in Political Science