Experience

Quality Compliance Partners, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Qulity Compliance Consultant

  • Jun 2019 - Present



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Quality Compliance Consultant

  • Jan 2017 - Jun 2019

  Data Integrity Investigator: Investigation of all laboratory operations, manufacturing operations, quality control, and GMP systems:Quality Management Systems:• Production Systems: Manufacturing/ Production Lines• Facilities and Equipment: Building, Equipment, Production Equipment• Laboratory Controls• Chemistry QC Laboratories• Microbiology QC Laboratories• Materials Systems: Warehouse• Packaging and Labeling• Quality SystemsOther GMP Elements:Including but not limited to: SOPs (as applicable to Data Integrity andQuality Management Oversight), Records, Laboratory Instrument Logbooks,Laboratory Notebooks, Deviations, CAPAs, OOS/OOT, ComplaintEvaluations, Product Stability Testing, Finished Product QC Test Data,Quality Trends, Control Charts, Annual Product Reviews, Product QualityAssessments (PQA), R&D Data, ANDA Documentation, Method Validations,Equipment instrument Validations and Qualifications, Computer SystemValidations, Recalls and Adverse Events, Calibration, Maintenance Records

• Sr.Quality Compliance Consultant: Client: ( Prescription Pharmaceuticals manufacturer)

  • May 2016 - Dec 2016

  • Aseptic Shop-floor monitoring of formulation/compounding, manufacturing, filling, inspection and packaging activities.• Observe operators in aseptic and TS areas for adherence to SOP’s and cGMP procedures.• Mentor and train operators towards improvement of operator techniques.• Provide a daily report of activities and also generate a scorecard of personnel’s knowledge of systems and procedures and their performances on the shop floor to upper management.• Help author and train the operations group for raising Attachment-Ks (Pre-deviation/Notification of Event) and Manufacturing Deviations with the MQA and QA personnel to ensure they are written, promptly, correctly and with requisite details.Follow-up of deviations to their logical conclusions up to Batch/product release



NNE Pharmaplan (Health and pet care manufacturer)

• Process Engineer. Manufacturing investigations

  • Feb 2016 - May 2016

  • Performs product impact and risk assessment, resolution, recommendations and closure of manufacturing investigations in a timely manner• Work with client’s third part project team to analyze and help resolve any operating issues.• Provides a routine trend report of manufacturing related investigation to the client’s third part project team to help with the release of the drug product. • Performs product impact and risk assessment, resolution, recommendations and closure of manufacturing investigations in a timely manner• Work with client’s third part project team to analyze and help resolve any operating issues.• Provides a routine trend report of manufacturing related investigation to the client’s third part project team to help with the release of the drug product.



Double Dragon Consulting Inc.

• United States
• Pharmaceutical Manufacturing

• Sr.Quality Compliance Consultant

  • Sep 2015 - Feb 2016

  • Perform retrospective and/or prospective review of batches per established protocols.• Prepare batch review checklists to document the review results• Identify laboratory data integrity issues• Prepare and execute validation documentation for laboratory instruments• Coach and mentor site QC and QA staff• Provide guidance, review, or draft deviation investigations as needed. • Perform retrospective and/or prospective review of batches per established protocols.• Prepare batch review checklists to document the review results• Identify laboratory data integrity issues• Prepare and execute validation documentation for laboratory instruments• Coach and mentor site QC and QA staff• Provide guidance, review, or draft deviation investigations as needed.

• Sr.Quality Compliance Consultant: Client: ( Prescription Pharmaceuticals manufacturer)

  • Jun 2015 - Aug 2015

  • Assisting client with conducting Quality reviews of Batch Records and associated documents.• Provide additional Quality support as request by the client management team• Report findings to the client management team.• Work with the client management team on implementing recommendations and producing deliverables in a manner that is consistent with all applicable FDA and other regulatory agency expectations and industry practices, as well as client’s policies and procedures. • Assist client with the review of the in process alert notifications associated with the Batch Records and assess impact to the product line.

• Quality Compliance Management Consultant

  • Sep 2013 - May 2015

  • Provide Regulatory compliance auditing and consulting to the client• Responsible for manufacturing batch record re-certification to allow client with an FDA hold on product to release product• Responsible for deviation investigation and remediation• Performing environmental monitoring trend analyses• Performing analytical data review in LIMS Labware • Provide Regulatory compliance auditing and consulting to the client• Responsible for manufacturing batch record re-certification to allow client with an FDA hold on product to release product• Responsible for deviation investigation and remediation• Performing environmental monitoring trend analyses• Performing analytical data review in LIMS Labware



Argos Therapeutics Inc., (Specialty Autologous Immunotherapy)

• Quality Assurance Supervisor

  • Oct 2012 - Sep 2013

  • Provide supervision to QA staff employees• Review and approve cGMP documentation including Item Specifications, SOPs, Master Production Records, Standard test Methods, validation protocols and reports• Author SOPs• Signature authority for Quality Assurance Manager• Oversee review and approves executed Batch Production Records, executed stability and validation protocols/reports • Manage Deviation, CAPA, and non-conforming materials systems• Develop and perform cGMP and Quality Systems training• Act as an advisor to QA and other departments regarding quality and compliance issues •Work on problems of moderate scope in which analysis of the situation or data requires a review of identifiable factors, such as those exhibited in Deviation Reports• Assist in product shipments, and review and release of incoming raw materials• Chair Material Review Board meetings• Perform internal and external audits• Perform raw material and final product release



Hospira (Specialty Generic Injectable Pharmaceuticals)

• Quality Assurance Auditor

  • Jan 2012 - Oct 2012

  • Lead and the go to person for the Laboratory analysts and other quality assurance personnel.• Meticulous Review of Validation, Engineering, QC laboratory and facility related documents with regards to GMP compliance, acceptance criteria and thorough investigations of anomaly events.• Lead in making sound decisions to meet quality compliance of FDA, EU, MHRA and product requirements.• Responsible for making Critical judgments and advising on observations during reviews of documents and discussions.• Execute oversight of Quality engineering activities such as validation protocol review, process and laboratory change control review, preventive maintenance review and approval, production support activities such as water systems, HEPA, P&IDs and changeover documentation.• Responsible for verifying the accuracy of raw data and demonstrate a good degree of initiative to resolve problems, discuss and research actions to be taken before finalizing a resolution.• Evaluate testing for compliance to all applicable SOPS and regulatory requirement.• Actively partnering with manufacturing, engineering, Quality control, quality assurance to ensure continued robust compliance and continuous system improvement.• Performs Vendor/Supplier Audits• Performs internal audits • Writes Audit reports and manages responses and documents audit close out.• Manages master vendor list and Audit schedule



Pfizer (Formerly Wyeth Biotech) (Vaccine Manufacturer)

• QC Lead scientist III

  • Jan 2007 - Jan 2012

  • Author and modify standard operating procedures and standard test methods to streamline day to day operations while adhering to cGMP guidelines.• Meticulous evaluation of laboratory data results to ensure compliance to procedures and acceptance criteria.• Thorough investigation of anomaly events.• Quick and sound decisions to meet quality compliance of FDA, EU, MHRA and product requirements.• Critical judgements ad advising on observations during reviews of documents and discussions and discussions,• Lead IQ/OQ/PQ activities for new technologies and instrumentation.• Train and transfer new technologies to QC release labs.• Manage agreed corrective actions and verify completion prior to closing. • Provide above-site support for regulatory inspections.• Perform gap assessments of new and revised policies with respect to global procedures.• Manage the change management system for the department.• Write and perform assay qualification protocols in accordance with ICH guidelines.• Create and change materials specifications. Help with investigations and root cause analysis for out of specification or anomalous results and atypical events that occur during QC lab testing of in-process and stability samples.• Help Communicate and coordinate with QA, Change control and document control to produce final reports that identify, correct, track and trend events and their root causes.

• Scientist II

  • Jun 2004 - Dec 2007

  QC scientist II • Planned and conducted with QA internal laboratory audits, commercial audits.• Helped convert the labs from manual data management system to LIMs labware systems.• Helped with the deployment of LIMS and instrument integration.• Helped with the Business reviews in preparation for LIMS Deployment.• Lead analysts on Lean lab projects.• Responsible for release testing of biological materials in the support of commercial and clinical manufacturing.• Review and revise validation protocols, instrument qualification, Laboratory procedures• Lead Audits and regulatory inspections.• Work across site and global departments to reduce waste, harmonize process, and increase overall productivity.• Maintained and calibrated instruments, including trouble shooting, and repair and qualif



Wyeth lederley Vaccines

• Belgium
• Legal Services

• QC Scientist I

  • Jan 2001 - Apr 2004

  • Maintained Equipment calibrations, troubleshoot methods and instruments.• Analytical test support for CRM, Hemophilus B Oligisaccharide (HbO) and (HbOC) conjugated material, PRP and Prevnar.• Mentored and trained current and new employees. • Co-analyst for method validation projects • Review, revise and develop SOPs, worksheets, training materials and other documents to comply with site and cooperate, cGMP and FDA guidelines. • Coordinated sample-testing needs with manufacturing staff and the QA release group.• Reviewed other analysts data for approval by QC management• Reviewed executed batch records in support of finished product release.• Performed investigational testing for manufacturing and laboratory discrepancies. • Coordinated sample due dates for in process, stability and final product.• Assisted with sample management and data management using (SLIM) for stability data. • Conducted internal cGMPs audits of production facilities, laboratories, quality systems and documentation.• Evaluated corrective action activities involving QC labs, materials, assay specifications, sample storage requirements, and acceptance criteria.