Anita Njiwah
Chicago,United States
Summary
Experienced and dedicated Lab Operations/Validation Associate with several years of experience identifying efficiencies and problem areas. Adept at receiving and sorting data from multiple data streams, Committed to bringing forth the highest level of support, and handling all duties in an eloquent and positive manner.
Overview
9
9
years of professional experience
Work History
Laboratory Validation Project Specialist
Pfizer
Lake forest, IL
03.2021 - Current
- Accountable for the planning and Laboratory protocol adherence and data quality of assigned laboratory projects in the Lake forest location, in accordance with scientific, medical and ethical principles and with GxP requirement guidelines
- Provide novel approaches to resolving problems and issues that may arise within the qualification and re-qualification of GMP and non GMP instruments
- Review Laboratory protocols and provides feasibility assessments on the ability to perform laboratory requirements and procedures
- Develop and setup laboratory capabilities and competencies required for conducting laboratory activities in lake forest in due time
- Ensure that the assigned projects are carried out following GxP, scientific, medical, and ethical principles, within regulatory requirements/guidelines, and standard operating procedures
- Work closely and communicate with all stakeholders (Lake forest colleagues & external vendors) for the management of the day to day quality activities for immediate & medium/long term problem solving, ensuring that project milestones are met
- Oversee the collection and documentation of assigned Laboratory study data
- Perform ongoing & regular quality reviews of our laboratory data for achieving audit-readiness.
Laboratory Outreach Analyst
California Department of Public Health (CDPH)
Remote
03.2019 - 03.2021
- Responsible for managing, analyzing and troubleshooting data related to lab results and interfaces for the California Reportable Disease Information Exchange (CalREDIE), a statewide electronic disease reporting and surveillance system maintained by the California Department of Public Health (CDPH)
- Communicate with data submitters, local health jurisdictions and partners
- Independently communicate with multiple representatives from all levels of data submitter organizations to provide details related to the electronic laboratory reporting (ELR) process, including technical messaging and vocabulary requirements
- Field questions and requests for assistance from the CalREDIE team, laboratories, local health departments, broader CDPH program staff, technical vendors and other partners and constituents
- Guide new submitters to appropriate channels for CalREDIE reporting
- Reconcile information from multiple sources to identify and troubleshoot issues
- Independently investigate and assist with resolving data transmission anomalies
- Conduct data quality analysis and other activities utilizing various reporting tools and metrics
- Document and communicate issues succinctly and in a timely fashion, escalating as needed especially those items affecting test and/or case counts
- Coordinate discrepancy resolution between the sending facility and the receiving local public health jurisdiction
- Develop training materials to document error monitoring and resolution process steps
- Clearly and accurately track laboratories' efforts to resolve issues and submit quality ELR messages to CalREDIE
- Update submitter contact list based on exchanges with laboratories, vendors and other partners
- Interact with CalREDIE staff and CDPH program partners to support data quality improvements.
Validation Consultant
Pinnaql
Philadelphia, Pa
02.2018 - 02.2019
- Support clients in preparing for the qualification; this includes the organization and co-ordination of kick-off and status follow up meetings with all involved parties
- Prepare the qualification documents (Plans, Protocols, Reports, etc.) and execute test scripts according to established procedures
- Execute and manage change controls
- Ensure that testing performed during all qualification/validation activities is consistent with approved protocols, policies, guidelines and SOPs, resolving all qualification discrepancies when applicable
- Write, investigate and review discrepancies and observations; perform root-cause analysis and identify corrective and preventive actions when required
- Perform temperature-mapping studies using Vaisala monitoring system, as part of the performance qualification of the -20 freezers, -70 freezers, -80 freezer +4 fridges and incubators
- Prepare final validation summary report for cGMP compliant manufacturing process validation
- Responsible for process validation, writing SOPs and executing URS for the Empower full life cycle validation for the chromatography system
- Perform risk assessments for computerized lab systems to access regulatory, business, and technical risk
- Experience using Maximo, Bionovia, Sales Force, Summit and Tru vault.
Lab & Facilities Data Associate
Biolabs
Philadelphia, PA
02.2017 - 01.2018
- Focused on leading data entry and verification activities on laboratory equipment to ensure proper working conditions
- Successfully coordinated performance maintenance on all equipments including the Evos and ibright Imagine system, and calibration of all pipettes on site, utilizing the Asset Tiger platform to manage, clean and store data on equipment and pipettes
- Skilled and experienced writer with strong communication skills, responsible for creating standard operating procedures, and test procedures for laboratory technical use
- Consistently demonstrated creative budgeting and management of lab inventory, saving company over $5000 on monthly expenses, not limited to consumables, reagents and equipment supplies
- Performed data entry and validation of carefully vetted hazardous chemical inventory via labguru, and manage database system
- Supported data entry/verification for special projects and process improvement activities
- Supported technical operations department improvement projects by collecting additional data and/or verification of data for technical reports.
Elisa/Data Review Scientist
Eurofins
Philadelphia, PA
12.2015 - 12.2016
- Determined that data was compliant and defendable based on industry regulations and methodology
- Ensured that the client received quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations
- Reviewed simple and complex routine and non-routine data (for three or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; ensured all work was performed according to GLP/GMP requirements and applied GLP/GMP in all areas of responsibility as appropriate
- Performed strategic data analysis and identified patterns to improve metrics
- Reviewed methods to ensure procedures are followed
- Authorized written reports (e.g., SOP, OMC, client reports).
R&D Data Analyst/Lab Operations
Akers Bioscience
Thorafare, NJ
12.2014 - 08.2015
- Independently reviewed laboratory data to ensure that regulatory compliance was maintained
- Maintained the highest level of proficiency in terms of the duties and responsibilities required of auditors
- Fostered a customer service attitude within and among laboratory personnel
- Ensured the laboratory data was in compliance with cGMPS, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality and accuracy
- Reviewed laboratory notebooks, logbooks, and records to ensure compliance to data integrity and accuracy
- Completed the remediation activities of all data reviews to ensure errors were appropriately corrected and documented following testing procedures
- Data reviewed the evaluation of raw data, as well as verification of final data integrity (i.e., calculations, adherence to SOPs etc
- Worked with laboratory staff and management to remediate comments and errors in documentation
- Updated documents / procedures as needed
- Pulled and maintained departmental metrics
- Served as departmental liaison with cross-functional stakeholders
- Participated in continuous improvement initiatives.
Health Data Entry Associate
Abbott Laboratories
Abbot Park, Remote, IL
12.2014 - 08.2015
- Performed data entry of occupational health services (including but not limited to physicals, vaccine administration records, PPD test results, titer results, vision tests and audiograms) in a timely and accurate manner
- Identified the type of medical document that has been received and data enter pertinent information from the document
- Determined if documents were completed, and clearly communicated what was missing when incomplete documents have been received.
Education
Master of Science - Management & Leadership
Western Governors University
Salt Lake City, UT12-2023
Bachelor of Science - Exercise Science
Southern Illinois University-Edwardsville
Edwardsville, IL08.2014
Skills
- Adaptability
- Ability to Work in a Team
- Communication
- Effective Time Management
- Microsoft Excel
- Ability to Multitask
- Data Analyst
- Snowflake, Jira and Rhapsody
- Documentation Lifecycle
Timeline
Laboratory Validation Project Specialist
Pfizer
03.2021 - Current
Laboratory Outreach Analyst
California Department of Public Health (CDPH)
03.2019 - 03.2021
Validation Consultant
Pinnaql
02.2018 - 02.2019
Lab & Facilities Data Associate
Biolabs
02.2017 - 01.2018
Elisa/Data Review Scientist
Eurofins
12.2015 - 12.2016
R&D Data Analyst/Lab Operations
Akers Bioscience
12.2014 - 08.2015
Health Data Entry Associate
Abbott Laboratories
12.2014 - 08.2015
Master of Science - Management & Leadership
Western Governors University
Bachelor of Science - Exercise Science
Southern Illinois University-Edwardsville