QA Associate II

Preeti Tiwari

***********@*****.*** linkedin.com/in/preeti-tiwari-3a528516a

Education

Barkatullah University Bhopal, India

B.S. in Chemistry and Biology June 1989 – June 1992

Barkatullah University Bhopal, India

Masters in Economics in Environmental Economics June 1992 – June 1994

Barkatullah University Bhopal, India

M.Phil (Economics) June 1994 – July 1995

Professional Experience/Responsibilities

Primera Analytical Solutions Cranbury, NJ

QA Associate II March 2023 – Present

Review and approve analytical and bioanalytical method validation/verification reports in compliance with cGMP/GLP regulations

Conduct review of raw data and testing results gathered from testing of raw materials, API, in-process samples, finished products, and stability samples

Review cell/gene therapy raw data generated utilizing ELISA, plate reader and Soft Max Pro (GLP &GMP)

Evaluate data and audit trails generated utilizing analytical tools such as HPLC, UPLC, GC, LC/MS, ICP-MS, XRD, Dissolution, Titration, etc.

Assist in writing and review departmental SOPs as required and ensure that defined quality objectives are met

Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with scientists to enforce Good Documentation Practice (GDP) for data integrity and accuracy

Manage and review critical QA documents such as Investigations, Incidents, Deviations and Change controls as required and identify corrective and preventive actions (CAPA)

Assist in training new QA employees

Ensure timely completion of the projects and approves Certificate of Analysis (CoA)

Cranbury, NJ

QA Associate I March 2021 – March 2023

Approved analytical and bioanalytical method validation, method transfer and qualification reports and assured that raw data is in compliance with cGMP /GLP regulations and follows Good Documentation Practice (GDP)

Performed weekly laboratory internal audit to ensure that all the reagents, chemicals and instruments used are in conformance with SOPs, cGMP and GLP regulations

Maintained critical documents such as investigations, deviations, change controls, SOPs, and logbooks

Identified the trends of system suitability failures and helped obtain a viable solution in compliance with cGMP and GLP regulations.

Provided support by carrying out thorough lab inspection to verify that all the reagents and equipment used are properly labeled and are in compliance with SOPs, cGMP and GLP regulations prior to regulatory and external audits

Evaluated audit trail for raw data and instrument logs in cGMP regulatory environment for laboratory data release

Maintained training records of employees and helped in archiving the data

Efficiently delivered and coordinated multiple projects in a timely manner

Cranbury, NJ

QA Assistant October 2019 – March 2021

Reviewed laboratory notebooks and associated documents for correctness of raw data and verified that all reagents, standards, and equipment used are within acceptance range and are in compliance with cGMP and GLP requirements

Analyzed and approved analytical testing results for raw materials, finished product, in-process sample and stability study sample and issue Certificate of Analysis (COAs)

Ensured compliance of testing with laboratory procedures, test methods and protocols

Worked with analysts and group leaders to promote Good Documentation Practice (GDP) and promote a cGMP environment

Reviewed raw data for method validation, method transfer, method verification, and method optimization reports

Reviewed audit trails on computer systems used to acquire and process data from instruments (e.g., Chromeleon & Empower)

Skills

GMP/GCP/GLP certification

Microsoft Office

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