Quality Compliance Engineer

Rufus E. Williams, Jr.

**** ****** **** *****

Unit# 218

Dublin, California 94568

*****.*********@*****.*** 909-***-**** (cell) 909-***-**** (home)

Quality & Manufacturing Management Leader with experience supporting global Pharmaceutical and Biotechnology Industries. Expertise managing plant startup operations and technical engineering projects including Commissioning, Validation Qualifications (IQ/OQ/PQ), Cleaning, Maintenance, Manufacturing, Quality, and Compliance Investigations, Deviations, CAPA, Change Control. Process improvement knowledge and experience in implementing and driving a continuous improvement culture through mentoring and professional development.

CORE COMPENTENCIES

●Investigations & CAPA, Deviations

●Aseptic/Sterile Processing

●Root Cause Analysis

●Formulation & Compounding

●Six Sigma / Lean Methodologies

●Change Control

●Track wise

●GMP/ Regulatory Guidance

●Non-Conformance, Complaints

●Clean Room Management

●Quality Systems

●Regulatory Compliance / Inspections

●Facilities, Water Systems, Asset Management

●Process, Equipment, Product & Facility Scale-up

Professional Experience

Novartis- Morris Plains, New Jersey-2019-2019

Quality Compliance Investigator ( Consultant)

Quality Compliance Investigator in support of manufacturing operational deviations

Lead facilitator for CAPA and Impact Assessments using Root Cause Analysis Methodologies

Triage operational procedural deviations for T-Cell Manufacturing Processes/ Static and Bioreactor

Pfizer -Kalamazoo, Michigan –2018-2019

Quality Operations Professional (Consultant)

Provide Quality floor support for all GMP Packaging operations

Project Leader for all Sterile & Non-Sterile Investigations, CAPA and Impact Assessments using Root Cause Analysis Methodologies

Triage operational procedural deviations/ Sterile & Non-Sterile Packaging

Performed Batch Record review for process variations, sterility results, analytical results prior to release

Disposition batch status, hold, release, impact analysis in accordance with GMP/ Regulatory guidance

Intarcia Therapeutics - Hayward, California –2017- 2018

Quality Compliance Engineer (Consultant)

Project Leader for Regulatory Compliance Initiative/ Instrument Risk Assessment

Project Leader for Facilities Equipment Gap Analysis

Initiated Change Controls for Equipment Modifications

Project Leader for all Facility Investigations, CAPA and Impact Assessments using Root Cause Analysis Methodologies

Monitored the PM/CAL program for GMP compliance or addressing Out of Tolerance, OOT

Review Analytical data on equipment calibration and readiness

Project Team member for Facility PM/CAL program and address any tolerance issues (OOT)

Project Team member for Maximo Asset Management Standard Operating Procedures/ Business Administration

Facilities Team representative for Sterility Investigation Impact Assessment on all facility assets

Authored Standard Operating Procedures/ Technical documents/ Equipment specifications using the Intarcia’s Electronic Management System, Veeva

Dr. Reddy’s - Shreveport, Louisiana – 2013-2017

Operations Manager for Oral Solid Dose

Managed twelve employees responsible for the Coating, Printing & Packaging Operations

Ensured adherence to all FDA guidelines and regulatory compliance

Project leader for the implementation of automated CIP (clean in place) which increased productivity by 50%

CMO/weekly audits of GMP operational procedures, compliance and regulatory

Completed gap analysis of training requirements and addressed deficiencies within a 90-day period

Exceeded the goal of $1.4 M in profit for the budgetary years

Conducted quality investigations/ product impact/CAPA

Project leader for the implementation of new transfer pumps which increased productivity by 70%

Neutrogena/Johnson & Johnson – Los Angeles, California - 2013-2013

Consultant/Compounding Investigations/CAPA/Compliance

Prepared and completed technical investigations based on deviations in the SOP’s /Batch Record Requirements

Wrote and revised Standard Operating Procedures (SOP’s) for the manufacturing departments in adherence with GMP guidance.

Identified and addressed all issues with equipment validation discrepancies

Conducted gap analysis for the manufacturing team to identify employee training deficiencies

Developed the departmental training curriculum

Focused on training & certification of employees which addressed issues relating to nonconforming FDA/GMP requirements in job functions

Avrio Biopharma (CMO) - Irvine, California - 2012–2012

Aseptic Manufacturing Manager

Management of projects related to aseptic filling processing; which included Clean Room Management, Autoclave Operations, and Lyophilization

Validated a new sterile filling suite and classified all rooms within the ISO 5 sterile filling suite

Validated a new state of the art filling machine which included the Factory & Site Acceptance Testing

Successful completion of filling validation process/media fills

Trained and certified all operators on Aseptic Gowning

Developed and implemented new batch records for all CMO’s

Developed the clean room management program

Gilead Sciences Incorporated - San Dimas, California - 2007–2011

Aseptic Manufacturing Manager of Aseptic Sterile Filling/Packaging

Managed a team related to aseptic filling processing which included Clean Room Management, Autoclave Operations and Lyophilization

Responsible for all solid dose filling activities from filling to packaging, focusing label recognition and efficiency using OEE

Accomplished the commissioning and implementation of a new solid dose packaging line on second shift

Exceeded the production plan in each of the three years under my management

Annual recipient of the “Values of Work Award” based on my contribution in teamwork, excellence, accountability, and FDA readiness

Co-managed a $10M operating budget, meeting the corporate target of 3% reduction

Launched three new solid dose products and one parenteral product

Worked with 3rd party for the development of the filling process of (3) phase II clinical products, CMO

Developed the clean room management program

Reviewed batch record analytical data; signature approval

Developed the SOP procedures for product containment of a sensitizer within the facility; developed the conversion process by which we converted from manufacturing a cytotoxic product to sensitizer

Annually implemented over $100K in cost reductions working collaboratively with external vendors

Sponsored the $15M scale-up project for the aseptic facility

DFB Biotech - Curacao, Netherland Antilles - 2003–2006

Director of Manufacturing

Plant oversite Director for Manufacturing, Maintenance, Quality, Purchasing and Validation departments

Extensive experience with Biological Fermentations, Cell Culture, Cell Bank

Main point of contact for FDA regulatory inspections

Member of the DFB Biotech Board of Directors as the liaison for the Dutch government

Developed robust efficiency plans increasing productivity annually by 15%

Developed remediation efforts for FDA audit removing regulatory restrictions

Implemented engineering programs that improved equipment readiness and reliability

Developed the yearly manufacturing projections to meet sales requirements based on customer demand

Tyco Healthcare - Raleigh, North Carolina – 2002–2003

Manufacturing Manager Filling and Packaging

Managed three shift terminally sterilized filling and packaging operation

Project Leader of automation vision system for packing line; cost reduction initiative

Provided leadership to all staff in the areas of manufacturing, cGMP’s and FDA regulations

Reduced labor, material, and operator deviations by 70%

Managed a $1M budget

Hoffmann La Roche - Totowa, New Jersey - 2000–2001

Aseptic Manufacturing Manager of Aseptic Sterile Filling, Packaging, and Maintenance

Managed a three-shift operation consisting of both maintenance and production staff

Implemented an automated filter integrity tester/quality initiative

Maintained the #1 rated factory from a labor performance and customer service perspective

Managed an $18M budget

Operations Manager of the liquids/oral dosage department

Cross trained in encapsulation and granulation operations

Virally Inactive Technologies - Melville, New York - 1997–1999

Manager of Aseptic/ Sterile Filling and Packaging

Managed the facility start-up through final FDA approval, including staffing and writing departmental SOP

Validated the Sterile Filling Process Equipment

Developed and managed a $4M budget

Researched vendor pricing for start-up operations and participated in all negotiations

Worked with PLC’s, Clean in Place (CIP), Steam Sterilization operating systems

Validated the following systems: Media fills and conformance lots, Aseptic /Sterile Filling Machine’s installation

Completed the Performance Qualification, Steam Sterilization Cycles, Autoclave Cycle, Gowning.

Developed the Clean Room Management protocols

EDUCATION & CREDENTIALS

United States Army, Captain, Honorable Discharge

Bachelor of Science in Biology – North Carolina A&T State University, Greensboro, North Carolina

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