QE Resume

SARLA RAHEJA

**** ******* ***** **., **********, IL 60564

H: 630-***-**** C: 630-***-****

*****.******@*****.***

SUMMARY

Tech Support Scientist / Quality Engineer with 10 years experience in the Medical Devices Industry. Major strengths include statistical analysis for specifications setting of diagnostic assays and test method validations. Additional competencies in project management and design change control management. Known as an excellent communicator who can work autonomously as well as on a team. A goal-oriented leader who is highly adaptable and can deliver results.

QUALITY AND TECHNICAL EXPERTISE

Test Method Conversion/Transfer: Carbamazepine, Ferritin, TCA, Cannabinoids, Benzodiazepine Free T3, CEA, Folate, CA 15-3, Free hTSH II, Estradiol, Testostorone

Specification Setting Tools: CV Profiler, Process Translator, Stability, S/C Rate match for Calibrators and Controls, Stock solution, Controls Concentration targeting, K404 for number of adjustments, Validity, Constant SD and Constant CV

Statistical Analyses: Material cross-over for stability, stability regression, % Bias to target for controls, Platform bias, Instrument, Run, Reps, Calibrator, Control and reagent lot to lot variability, total test method error and platform specification capability

Common Test Method Validations: Spectrophotometric Peroxide assay, AxSYM LH Titration, AxSYM CEA, AxSYM Folate, Architect Folate Binding Protein, Architect Free T3

PROFESSIONAL EXPERIENCE

ABBOTT LABORATORIES, Abbott Diagnostic Division, Abbott Park, IL 2000 – 2011

Tech Support Scientist / Quality Engineer - Test Method Conversion/Transfer (2008 - 2011)

• Led multiple Test Method Conversion/Transfer projects achieving agreement on new specifications.

• Increased product availability by resetting acceptance and validity specifications.

• Developed specifications and sampling plans for new medical devices.

• Remediated test method specifications 100% to meet FDA commitments.

• Managed design control activities through EPAS system by routing approval of specification summary table, specification requirement documents, exception reports and Product Acceptance Specifications reporting in Design Records Database for various assays.

• Demonstrated extensive knowledge of specification setting requirements and inputs developing new specifications for platform conversion, remediation and transfer codes.

• Proficient in various statistical analyses- material cross-over for stability, stability regression, % Bias to target for controls platform bias, Instrument, Run, Reps, Calibrator, Control and reagent lot to lot variability, total test method error to accelerate specification setting input requirement procedures.

• Excellent Project Management skills.

• Organized and analyzed data required for spec-setting processes finalizing newly developed acceptance and validity specifications for diagnostic assays.

• Revamped the current acceptance and validity specifications for Customer Release Codes aligning specifications for in-process codes for transfer and platform conversion products.

• Proficient in performing Cognos queries from Idea Data Warehouse completing historical data evaluation.

• Evaluated new specifications impact for conversion/transfer codes predicting long term pass/fail rate.

• Successfully led weekly Cross Functional Team meetings to get approval on proposed specifications for Transfer/Conversion assays. Recommended current specifications and manufacturing processes changes.

• Accelerated specification setting processes by mentoring the new team members.

• Delivered results accurately in a timely manner to meet timelines to achieve departmental goals.

• Good understanding of cGxP (GLP, GCP, GMP), QSR, ICH guideline, Good Automated Manufacturing Practices and International Organization of Standardization (ISO) regulations and guidelines.

• In depth knowledge and expertise in presentation, graphs, flowcharts and documentation.

• Ability to work independently and effectively in a cross-functional team environment.

SARLA RAHEJA Page 2

Tech Support Scientist; Test Method Validation, Analytical Tech Services (2005-2008)

• Completed Test Method validations/amendments for diagnostic assays improving efficiency in customer's hand. Received approvals on change records efficiently expediting manufacturing processes.

• Initiated an analytical test method validation for Spectophotometric peroxide assay.

• Increased product availability by expediting various test method validation processes.

• Developed analytical performance characteristics limits completing test method validation.

• Extensively authored and updated requirements, validation protocol, qualification documents (IQ/OQ/PQ), and summary reports and used Good Documentation Practices (GDP) in the compliance environment.

• Worked on preparing key deliverables like Validation Run protocols and Validation Summary Report for Various test methods – Diagnostic assays for regulatory and 21 CFR requirements.

Advanced Process Specialist; HbsAg Lane Focused Factory (2003-2005)

• Assisted in Process Characterization and validation studies improving common processes.

• Provided technical support for test method validations to accelerate product availability.

• Performed investigation studies and severity assessments for failure codes in testing to stop re-occurrence.

• Established Non-Conformances (NCR’s) for failed lots during manufacturing; identified and documented the corrective and preventive actions.

Advanced Product Specialist; HbsAg Business Team: (2001-2003)

• Tested Quality diagnostic reagents using multiple technologies-Radio Immunoassay (RIA) and Enzyme Immunoassay (EIA), gaining proficiency.

• Routinely utilized the CAPA network system to document investigations identifying and documenting corrective and preventive actions.

• Established Invalid Rate Determination packages for RIA and EIA assays predicting validity of test method.

Test Method Validation Scientist; Thyroid / Fertility Test Method Remediation: (2000 – 2001)

• Created IMx Estradiol common test method application worksheet, determined assay performance based on RTME and Cp assessment adjustment and alignment of specifications to pass RTME and Cp goals of assay and assimilated the changes in testing documents.

• Completed Risk assessment for failed process capability of IMx Estradiol assay.

MORTON GROVE PHARMACEUTICALS, INC., Morton Grove, IL. 1999 – 2000

Regulatory Affairs Associate

• Assembled Regulatory drug submission to FDA.

• Assured compliance with the regulations set forth in Drug Act, including cGMP and cGLP.

• Monitored Regulatory subscriptions/references.

DIATEC ENVIRONMENTAL / ALLIED COLLOIDS, Batavia, IL 1989 – 1998

Research & Development Chemist

• Performed various duties in the Research & Development Division to support chemical synthesis.

• Experience in operation and maintenance of analytical instruments including HPLC, IR and refractometer.

• Developed Quality Control Manuals/Procedures

• Formulated all the products to manufacture and the samples under evaluation.

EDUCATION

Masters of Science (Bio-Chemistry), Nagpur University, India

Bachelor of Science (Micro-Biology), Nagpur University, India

PROFESSIONAL DEVELOPMENT

Certified Quality Engineering

Investigation JMP Basic Data Manipulation

JMP Hypothesis Testing: JMP DOE

Concepts for Acceptance Sampling Plan

JMP Control Charts Fit Model

SAS Training

Situational Leadership

AWARDS / RECOGNITIONS

Abbott Laboratories Silver and Bronze Awards

Technical Advisory Board (TAB) Member/Co-Chair

Asian Cultural Network; Indian committee Chair

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