Quality Manager

Accomplished and highly experienced cGMP Quality Assurance Professional with regulations of Title 21CFR 210/211 Part 11 and Title 21 CFR Part 820. Strong experience with Change Control activities and overall Quality Assurance systems, Procedure and technical writing. Strong management and organizational skills.

GMPs

Change Control

Validation and Review

Investigations and CAPA

Manufacturing GMPs Shop Floor

SOP writing- QA Documentation

Review and Approvals of regulated documents

APR review

Risk / FMEA

Work History:

HRA Pharma- Morristown NJ

Real Staffing- Real Sciences.com -Contractor Part time temp.

For startup company- Affiliate Medical Affairs.

Quality Assurance Manager December 2018- End of Jan 2019

Creating Quality Assurance and Compliance platform

Quality Manual document creation

Applications Used: SharePoint, PRISM

Sanofi-Genzyme- Ridgefield NJ

TalentBurst- Consultant

Sr. Compliance Specialist III June 2017- Sept 2018

FMEA- Failure Modes and Effects Analysis- Risk tracking and strategies

Injectable Medical Device experience with Products Synvisc Synvisc One and Jonexa.

Manufacturing and Preventive Maintenance Risk

Quality Testing oversight as it pertains to risk

Post market surveillance analysis and of patient exposure- Pertaining to Synvisc and Synvisc One.

Oversight to scoring FMEAs and updates to risk analysis documents and SOPs as it pertains to Manufacturing Risk

Living Risk Reviews from analysis of Periodic Product Reviews of products, Synvisc and Synvisc One – medical device injectable, Also living risk assessments for products Jonexa, Lovenox, Hectorol and Kynamro,

International collaboration with peers for product Synvisc / Synvisc One for internal and FDA audits.

Deliverables management of assessors and tracking

Management review presentations preparations

Investigations as it pertains to events that require risk management

Change control as it pertains to risk management oversight and approvals (manufacturing, equipment, QC testing / lab, labeling, packaging.)

Applications used: LiveLink document database / Gibralter-GEODE+ / Trackwise

PerkinElmer Servicing Regeneron - Rensselaer NY July 2015- July 2016

Team Lead Quality Manager - Consultant

Lab Systems Support supervision as it pertains to managing personnel and deliverables for Lab Computing, Computer Systems Validation, Application Development and Scientific Data Services management. Quality oversight to

Automated control systems.

Process improvement >

Change Control >

Preventive Maintenance oversight >

NOE- Notice of Events- Investigations >

Compliance and Quality, cGMP / cGXP > cGAMP Good Automated Manufacturing Practices for the Biotech and Pharmaceutical industry.

Systems used: DocCompliance, Process Compliance QUMAS, BMRAM -Blue Mountain Regulatory Asset Manager

Quality Assurance Engineer III

Software Galaxy Systems, Consulting agency. Skillman, New Jersey July 2013 – May 2014

Servicing Johnson & Johnson Quality Systems and Compliance assignment

Initially brought in for a 6 month assignment, which was extended to 10 months. Quality Assurance Systems support for contractor operations that service J&J consumer products. (Assignment completed successfully on time in May 2014.)

Managed 2 contractor Distributor / Supplier sites. Packaging operations quality support, responsible for cGMP Audits. Supplier / Distribution quality systems – QA External manufacturing.

Auditing of distribution sites, tours, documentation audits, cGMP, cGXP.

Involved with Investigations and reviews, involved in CAPA and Remediation working with the manager of quality to ensure implementation of plans and corrective measures to remediate label corrections and creating procedures for various quality functions. Quality liaison working with cross functional teams.

Prepared audit reports and a broad range of writing of SOP’s, Policies, Quality Agreements as required.

Labeling and Reviews: Batch record / Specifications Quality review and release for launching new and existing OTC and Cosmetic consumer products. Release of finished product- First Article Inspections- Consumer skin care and delivery systems medical device products. Inspection of labels and bar codes.

Customer Logistics Services and External Manufacturing Quality Assurance, which involved Quality support to supply chain management and ERP (Enterprise Resource Planning systems) for inventory control and Validation of ERP Projects that also involved change control for ERP system that interfaced with J&J’s SAP system in order to remediate audit observations to bring the distribution contractor up to acceptable status.

Global Change Control experience to provide information of status of CMO’s such as disengagements, changes in processes, procedures and products. Trained colleagues on change control functionality.

Applications Utilized: SAP, GSS, Symphony-EtQ- for Audits, Global Change Control, SharePoint.

Quality Assurance Systems Specialist- Sr. Auditor Elmsford, NY March 2009 – January 2013

San~Mar Laboratories Inc. - SML Acquisition, LLC. Process Technologies & Packaging Inc.

Quality Assurance for OTC Pharmaceuticals - Skin Care and Personal Products – Liquid Oral dose OTC’s cold medications

Managed 4 area managers and 20 QA personnel through Sr. Auditing and cGMP supervision.

Created and implemented internal auditing programs, formal audit templates and Quality Systems / SOP writing and approvals.

Lead in Internal Auditing of all shop floor operations and housekeeping. Hands on Experience, with third party auditors and FDA tours and inspection readiness.

Strong Technical writing experience for validation reports for manufacturing, Filling and Packaging for multiple OTC products.

Acceptable Quality Limits (AQL) adherence oversight.

Investigations handling, CAPA, Risk Assessments, Complaint handling-Adverse Events and other types of complaints. Quality oversight to Quality Control testing to ensure chemical and microbiological reports were completed and utilized proper USP guidelines. Complaint handling, creation of Complaint SOP, Forms, Tracking systems cGXP, Sample receipt of Adverse Events and other types of consumer complaints, QC interaction to ensure completing and results of assays and micro testing of complaint samples and investigations handling and follow ups and liaising with customers to ensure closure of complaints and investigations of required time lines. .

Lead Auditor and Trainer and Train the Trainer; for Lab operations, R&D, cGMP, annuals, change control, cGDP documentation practices, investigation MIR training, cleaning cGMP equipment and functional areas, cGLP sampling techniques quality control. Microbiological oversight, bulk and finished product, and raw materials.

Labels and Reviews: Lead in Batch Record / Production Record Review and Release operations.

Created performance objectives / manager review assessment and assisted QA Director.

Customer Interface with QC, sales, operation planners, technology transfer and R&D.

R&D and Technical Transfer Quality Assurance Oversight for new products for piloting. QA oversight to product development, working with sales on formula creation regarding quality and regulatory requirements when implementing new product lines- scale up. Analyzed Stability and Analytical Quality control documents for compliance and to create protocols. USP <61> <62>.

Lead in Vendor Qualification for Contract Laboratories needed for Microbiological studies.

Regulatory and Compliance. NAFTA Agreements, cGMP letters of Compliance, Licensures (FDA) (QA/RA) APR (Annual Product Review) writing experience, readiness and Quality Agreements

510K Submissions for delivery / application device for personal care and skin care OTC product(s)

Final reviews of MDR’s.

Involved in Startup operations and qualifications (QA / RA) oversight for new facility. Quality and compliance oversight to validation documentation and equipment maintenance. (IQ,OQ,PQ) Critical equipment and facilities oversight.

Quality Assurance Specialist II - Technical Operations – Internal Audits

Wyeth Corporation Pearl River NY November 1999-October 2008

Quality Assurance –Vaccines-Biotech

QA Lead and Original compilation of all data pertaining to cross batch critical and batch specific equipment to create QA global audit procedure and system that governed quality assurance internal activities to ensure qualifications and validation of equipment. GXPharma system used for SOPs.

Team Auditor for internal shop floor, EM Audits, critical equipment and documentation, cGMP, cGLP, cGCP, cGXP. CAPA to 483 observation / Consent decree experience. ICH guidelines, Title 21 210 / 211 QA Engineering.

Validation Support- Technical writing QA support to engineering, equipment and creation of electronic systems.

Performed critical equipment auditing within all GMP GLP GCP and FDA regulations and ancillary compliance issues pertaining to cross batches specified. Prevnar and HibTiter Vaccines. Managed projects for critical equipment that supports vaccine production. QA oversight and advisory to validation process for IQ, OQ and PQ of cGMP Critical Cross batch equipment. Parameter compliance oversight and maintenance QA oversight for all Primary Process Units. Alarm system Validation oversight to

Chill rooms, Freezers and Stability Chambers- Change Control Management

Worked with Maintenance with providing equipment data. MAXIMO Work order distribution system used.

Provided Quality Assurance with support in maintaining documents and monitored critical equipment needed for temperature recordings ICH guidelines- Chill room and Freezer, incubation storage conditions / differential pressure values and HVAC / AHS systems in critical areas where product is made and stored. Room Classification.

Provided QA oversight for data processing for parameter and actual readings to monitor all GMP critical equipment and status. Documentation experience overall for Polysaccharide production associated with the production of Pneumococcal Polysaccharide Vaccines, Pneumococcal Conjugate Vaccines and Glycoconjugates of Bacteria Carbohydrate and Streptococcus Pneumoniae. Prevnar 13 Valent.

Performed activities and duties that provide quality oversight and guidance, when necessary for the manufacturing process when critical processing steps are conducted.

Worked with Production, Compliance, Engineering, Maintenance, Technology and Manufacturing to find a decision flow for events and to provide support for immediate corrective actions when needed. Participated in Internal and External Audits (including assistance with FDA / BOH, corporate audits, senior management, “5S team” housekeeping audits, safety, and self-inspections), as necessary.

Provided oversight and authorization for operations or to proceed at risk under certain conditions pertaining to disruption to controlled environment, or growth sighted on purity growth plates in fermentation process if organisms have been recovered. Provide guidance when change of product from development to commercial status and start up and shut down activities oversight.

LIMS (Laboratory Information Management Systems) data base experience for quarterly water samples.

Assisted QA Release Officer to release materials to manufacturing.

Manufacturing investigative reporting MIR experience –CAPA Corrective and Preventive Actions / Commitments. Trackwise application used to initiate and write investigations.

QA Support with Complaints, Investigations tracking and follow ups through audits.

Oversight with environmental monitoring documentation for batch records for releasing product. Current Aseptic practices used.

SAP, distribution inventory system knowledge and used.

Worked with IT personnel and QA Team to advise needed QA functionalities to build a software database for auditing purposes.

Verification of Batch Record Data- MIND data application. Assisted with Greenbelt projects and project management. Lead Safety Representative and statistical reporting for primary processing unit.

Biological Analyst - Scientific Assistant

Wyeth / Lederle Vaccines and Pediatrics Pearl River, NY September 1998-November 1999

Quality Control / Clinical trials / Safety / Stability – cGMP, cGCP, GLP – Various vaccines / Oral dose OPV

Surgical Technician/Scientific Assistant

Lederle / American Cyanamid- Wyeth Pearl River, NY September 1993-September 1998

Primate unit Live Polio Vaccine Production (Orimune OPV)- cGMP, cGLP, cGTP- Oral dose (Primary Tissue Culture Preparation)

Other Experience:

(Tew QA Systems Consulting Services) - Since: January 2013-

Quality Assurance Systems Consultant for Quality Assurance Management and Technical Operations for cGMP / cGXP Manufactured products.

Companies serviced:

Process Technologies & Packaging Elmsford NY & Olyphant, Pennsylvania

Libra Technical Center Metuchen New Jersey

Provided periodic consulting services for cGXP / cGLP Lab operations: Quality systems creation and oversight involved the Preparation of SOP’s for various quality systems that needed to be in place that was an observation by the FDA for Libra Technical Center. SOP - Train the Trainer and Staff Trainer for Libra Technical Center.

Annual Product Review preparations.

Auditing service provided for cGLP, cGMP and cGXP

Executing the System Audit performed using the requirements, which are written with consideration to the general guidelines contained in ISO 19011, Guidelines for quality and/or environment management systems auditing. To execute a plan following the exact regulations that pertain to the product made as it pertains to under cGMP requirements. Plan following the beginning phases of product development to piloting and then to commercial status of the product. Close out and follow up CAPAs for observations.

Involved in change control and validation for the transfer of equipment and quality systems to the Pennsylvania site for Process Technologies and Packaging.

Other services:

Supplier oversight experience as Quality Assurance

Quality Agreements

Managing Staff for deliverables appropriate for servicing clients.

FMEA – Risk Analysis

Fluent in many electronic applications used for cGXP / cGLP / cGMP operations.

Education

NYIT Old Westbury, Long Island, NY- Bachelor of Science

Major: Science, Behavioral, Organizational behavior, Social work

Minors: Biology, Management, Professional Writing- English Literature.

GPA 3.69 Magna Cum Laude

Other Schools and Certifications

SUNY Rockland Community College:

Studies: Biology, Chemistry, Humanities English Literature

AALAS Certified. Lab Animal Technician/ Assistant

CAPA Certificate of Recognition / Certified- Best Practices

Aseptic Gown Certified- Wyeth Vaccines

Lean 6 Sigma Certified-Simulation program

Safety Officer Certificate of Recognition

Business communication and management Certificate

References Available upon Request

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