Quality Manager
Resume:
Larry D. Butler
Bartlett, TN 38135
Phone: 203-***-****
Email: ***********@*****.***
Summary of Achievements:
Results oriented Pharmaceutical QA and QC Laboratory professional with over 25 years management experience.
I am seeking a management position within the quality organization of a pharmaceutical/medical device/biotech company.
Validation:
Perform equipment and process validations (i.e., IQ/OQ PQ and were responsible for evaluating laboratory equipment
such as HPLC, GC, and Spectrophotometer. Accessing the processes of evaluation and tracking.
For process validation evaluate:
Process Design such as commercial process through development and scale-up activities.
Process Qualification reproducible commercial manufacturing.
Continued Process Verification routine production that the process remains in a state of control.
Cleaning Validation.
Types of Process Validation performed:
Prospective Validation – Validate the process for a new formula (or within a new facility) must be validated before
routine pharmaceutical production.
Concurrent Validation - Monitoring of critical processing steps and end product testing of current production, to show
that the manufacturing process is in a state of control.
Revalidation:
-The transfer of a product from one plant to another ( Transfer from Carmel, NY to Davie, FL)
-Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
-The necessity of periodic checking of the validation results.
-Significant (usually order of magnitude) increase or decrease in batch size.
Other functions:
Performed non-conforming evaluation on product in a QC and QA environment.
Establish and track CAPA throughout the process.
Perform internal and external audits for CMO, Suppliers and Distributors. As well as for the FDA, DEA and EPA.
Troubleshoot equipment and instrumentation for both laboratory and manufacturing.
Assist in Continuous Improvement at Watson and Dendreon to improve efficiency with personnel.
Review and approve documentation for such documents such as SOP and GTP as the SME.
Develop and establish Training Program at Watson and Central Pharmaceuticals.
Worked two years at Steris Laboratory and Dendreon under a sterile environment where it was a Class 7 and 8 ISO environments.
Develop programs and develop process under two Consent Decrees.
Experience with various software: Word, Excel, Pivot Table, power point, etc.
Professional Experience
Quality Engineer RMS Surgical Memphis, TN
06/15/2015 – present (Contract)
Instrumental in addressing issues from a previous 483 by the FDA, review and address issues pertaining to open and close CAPA, address Customer complaints, perform deviation/investigation as well as Continuous Quality Improvement (writing and approving quality documents…SOP’s). In accordance to ISO 13485 and ISO 9001; 21 CFR Part 820 and cGMP. Also perform and wrote training procedures for the Quality Department.
Quality QC Manager Cytovance (Biopharmaceutical) Oklahoma City, OK
04/06/2015 – 06/07/2015 (Contract)
Review and perform open and close CAPA, perform deviation/investigation as well as Continuous Quality Improvement (writing and approving quality documents…SOP’s). Responsible for establishing a stability department which included scheduling of stability products and personnel to perform the test. Approve test procedures from in-house and from Customers. Cytovance operates in conjunction to FDA part 210 & 211, 600, 610 and 820. It also operates under the guidelines of ICH Q6A, Q6B, Q7, Q9, Q10 and Q11.
Sr. Quality Engineer Zimmer (Medical Device) Warsaw, IN
08/18/2014 - 03/15/2015 (Contract)
Perform closed and open CAPA Investigation and Remediation as well as QIR Customer Complaints and SCAR for product produced by Zimmer and their affiliates in conjunction to ISO 13485 and ISO 9001; 21 CFR Part 820 and cGMP.
Quality Consultant UCB Pharma Atlanta, GA
9/2013 – 1/2014 (Contract)
Review and Revised CAPA.
Performed Investigation and Deviation on manufacturing process.
Change Control.
Complaint procedures to align with current contract operations.
Perform Quality Audits (external and internal) in accordance to 21 CFR 210 and 211 and CFR 21 110 and 111.
Perform Annual Product Review (APR).
Used SAP by third part logistic to ship product.
Quality Manager Arbor Pharmaceuticals Atlanta, GA
1/2013 – 9/2013 (Downsized due to loss of business)
Managed activities associated with seven contract Manufacturing/Laboratory facilities.
Final internal review and approval of batch record and laboratory data received for manufacturing activities associated with Arbor products.
Developed consensus with contract facilities for timely communication and receipt of investigation data related to Arbor products for timely distribution of product.
Created and implemented internal Out of Specification (OOS) procedure that established guidelines for management of contract facilities’ reported OOS values.
Performed Investigation and Deviation on manufacturing process.
Revised CAPA, Process Failure Mode Effects Analysis (PFEMA), Change Control, and Complaint procedures to align with current contract operations.
Trained Arbor personnel to revised/created procedure to assure uniform compliance.
Perform Quality Audits (external and internal) in accordance to 21 CFR 210 and 211 and CFR 21 110 and 111.
Perform Annual Product Review (APR).
Compose and revise Quality Agreement.
Used SAP by third part logistic to ship product.
9/2012 - 1/2013 Altora Pharmaceuticals Smyrna, GA
Management Consultant
Assisted in establishing a supplemental facility. Wrote SOPs and develop validation procedures for equipment. Assist in hiring personnel.
5/2010 – 5/2012
(Downsized due to loss of business)
Dendreon
Union City, GA
Supervisor Quality Systems/Laboratory Operations – Supervised 5 quality personnel
Performed internal audits in preparation of agency inspections to assure facility compliance to FDA 21 CFR 606 and 21 CFR 640 and corporate policies.
Created local CAPA, Process Failure Mode Effects Analysis (PFEMA) and out of specification (OOS) procedures to align with internal operations while complying with agency guidelines and corporate policies.
Performed final Quality review and approval of patient packet for shipment of infused blood. Patient packet is also termed as batch record which contained documentation of blood sample receipt, identification of protein substance used for infusion, test analyses performed, equipment used throughout process and confirmation of compliant documentation practices by responsible personnel engaged in process.
Final Quality reviews and approval of related CAPA activities, out of specification (OOS), and complaint and investigations/deviations were maintained in Oracle database.
Perform Change Control.
10/1992 - 4/2010 Watson Pharmaceutical Carmel, NY/Davie, FL
Downsized due to loss of business
Laboratory Supervisor (2008 – 2010) – Supervised 12 laboratory personnel (Davies, FL)
Final Quality Control review and approval of laboratory Out of Specification reports.
Supervised additional review of laboratory data (when necessary) in support of necessary batch record reviews for manufacturing investigations.
Final Quality Control review and approval of laboratory Out of Specification reports.
Supervised additional review of laboratory data (when necessary) in support of necessary batch record reviews for manufacturing investigations.
Teamed with fellow managers for performance of annual manufacturing and laboratory internal audits.
Final Quality Control review and approval of laboratory related CAPA activities, out of specification (OOS), and laboratory complaint investigations maintained in site TrackWise database.
Laboratory Manager (1992 – 2008) – Managed 25 laboratory personnel (Carmel, NY)
Managed training and curriculum development program for laboratory personnel resulting in reduction of laboratory investigations by 25%.
Final Quality Control review and approval of laboratory Out of Specification reports.
Supervised additional review of laboratory data (when necessary) in support of necessary batch record reviews for manufacturing investigations.
Responsible for maintenance and development of General Training Procedures and SOPs for laboratory equipment and personnel as needed for new hire laboratory employees and current certified personnel.
Managed Laboratory Control Center for the purchasing, distribution, and maintenance of laboratory equipment, worksheets, and manufacturing samples.
Implemented Laboratory Safety Program and Perform Change Control.
Teamed with fellow managers for performance of annual manufacturing and laboratory internal audits.
Final Quality Control review and approval of laboratory related CAPA, Process Failure Mode Effects Analysis (PFEMA) activities, out of specification (OOS), and laboratory complaint investigations maintained in site Empower database.
Perform Risk Management on products and procedures.
This facility is operated in an ISO 9001:2008 and cGMP environment.
The federal agencies in which has an impact at this site are: FDA, EPA, DEA, and OSHA
System used in maintaining data was Empower and LIMS.
Responsible for validations and method transfers and perform equipment and process validations.
Additional Accomplishments
In 1994, I was instrumental in re-establishing Schein/Watson Pharmaceutical laboratory operations to align with commitments of voluntary Consent Decree for Carmel, NY and in 1998 a non-voluntary Consent Decree at the Phoenix, AZ facilities. Project included the following.
Procedure development to support new laboratory processes and improved Metrology (IQ/OQ/PQ) program
Institution of multi-site Laboratory Training and Certification Program.
Institution of improved Laboratory Investigation/Troubleshooting process.
Inventory Control and Tracking.
Institution of Laboratory workstations to improve efficiency and cost reduction:
1990 – 1992 Central Pharmaceuticals Seymour, IN
Central Pharmaceuticals
Seymour, IN
Quality Operations Manager/Chief Chemist
Responsible for management of Quality Systems and controls while overseeing performance of 35 personnel for a Contract Manufacturer.
Performed equipment validations,
Performed Change Control
1982 – 1990 Boots Pharmaceuticals Shreveport, LA
Senior Chemist
Research and Method Development Scientist-Familiar with various instrumentation such as:
HPLC, GC, AA, UV spectrophotometry and various wet chemistry methods etc.
Education:
Boots Pharmaceuticals
Louisiana State University, Shreveport, LA;
B.S., Chemistry - 1982
Membership Affiliations
Alpha Phi Alpha Fraternity, Inc.
Sertoma Club
Member of American Chemical Society
American Analytical Pharmaceutical Association
References
References are available upon request.
Contact this candidate