Manager Quality Assurance

SCOTT K. SMALLBROOK

***** **** **** ************, ** 17363 410-***-**** ************@*****.***

Objective: quality assurance manager

Extensive background in Quality Assurance, Operations and Technical services, including experience in the successful implementation and oversight of systems associated with quality management, Quality Assurance review and approval of new or modified products and regulatory submissions.

Demonstrated professional expertise and leadership in the Quality function as it relates to CGMP and PAI FDA inspections and internal / external audits.

Quality Assurance Skills

CGMP Inspections

PAI FDA Inspections

Internal/External Audits

Implementation of Quality Management Systems

Document Control Management

Oversight of Quality Systems

CAPA

Design and Track Quality Metrics

Vendor Accreditation Programs

Labeling Compliance

Documentation Support

Implements and Enforces Quality Standards

Supervisory Skills

Regulatory Agencies

Deviation/Investigation Resolution

Professional Experience

EMERGENT BIOSOLUTIONS - BALTIMORE, MD

Quality Assurance Engineer – 02/2016 to 12/2016

Investigated, wrote and obtained approvals of complaints and deviations; developed and implemented CAPAs.

GLAXOSMITHKLINE – MARIETTA, PA

Quality Assurance Specialist – 06/2015 to 10/2015

Monitored the activities of the packaging lines during the building of inventory for flu vaccines;; duties included on-line monitoring, sampling, AQL inspections, batch record review, log book review, etc.

4-1-1 CONSULTING SERVICES, LLC – YORK, PA

Quality Assurance Consultant – 05/2013 to Present

In a consulting role: research and recommend licensures required for pharmaceutical companies; write Standard Operating Procedures (SOPs) on complaint handling, document management, auditing program, vendor accreditation program, and regulatory agency inspections; prepare and execute Powerpoint presentations on dietary supplements, good documentation practices, document change control and good manufacturing practices for training of pharmaceutical companies

NEXT BREATH, LLC. – BALTIMORE, MD

Quality Assurance Manager – 03/2005 to 05/2013

Manage activities involved with the successful implementation and oversight of systems associated with the quality management of a contract research organization.

Key Results:

Two successful CGMP and PAI FDA inspections with no 483 observations; Management of Quality Systems including CAPA, internal/external auditing, document management system, training program and calibration system; creation of laboratory protocols; review and approval of laboratory notebooks; resolution of deviations and investigations; successful accreditation of ISO/IEC 17025:2005.

JEIVEN PHARMACEUTICALS CONSULTING, INC. – Scotch Plains, NJ

Senior GMP Compliance Consultant - 12/2004 to 03/2005

Conducted CGMP and GLP compliance audits of API and finished dosage form manufacturers, domestically and internationally, and developed CAPA initiatives.

Key Results:

Conducted a CGMP audit in China of two API manufacturers for finished nutraceuticals (chondroitin and glucosamine).

ADVANCIS PHARMACEUTICAL CORP. Germantown, MD

Associate Director, Quality Assurance 11/2003 to 11/2004

Directed activities involved with the successful implementation and oversight of systems associated with the Quality Management of clinical trial manufacturing and in-licensing of oral solid dosage pharmaceuticals.

Directed the activities of three associates.

Key Results:

Established Quality Systems including CAPA, internal/external auditing and vendor accreditation programs resulting in compliant contract laboratories, CMOs and vendors; established Corporate Quality Manual, Quality Agreements and Supply Agreements; coordinated design and validation of electronic SOP and document management system (i.e. Trackwise); coordination of the activities associated with the validation and implementation of a CGMP compliant pilot plant.

CHESAPEAKE BIOLOGICAL LABORATORIES, INC. Baltimore, MD

Associate Director Quality Assurance/Regulatory Affairs Systems 10/2002 to 11/2003

Directed activities involved with the successful implementation and oversight of systems associated with the Quality Management of small volume parenteral drugs, biologics and veterinary products and medical devices within a contract manufacturing organization.

Directed the activities of three associates.

Key Results:

Administered internal and external auditing and vendor accreditation programs resulting in successful pre-approval and biennial CGMP inspections from CDER, CBER, Health Canada, CDC and EMEA; hosted 45 client site audits, conducted 38 internal and 7 vendor audits; analyzed and trended observations for implementation of improved CAPA and change control programs.

ATLANTIC PHARMACEUTICAL SERVICES, INC., - Owings Mills, MD

Quality Assurance Manager 04/1999 to 10/2002

Management of Quality organization for multiple facilities of the manufacturing of solid dosage bulk and intermediary pharmaceutical drug products.

Directed the activities of ten QA Technicians in two facilities of a 24/7 operation.

Key Results:

Managed successful pre-approval inspections from USFDA and EU; implemented on-line QA program for improvement of CAPA program and 24/7 operation; developed and implemented a Master Validation Plan for facility expansion.

ALPHARMA, U.S. PHARMACEUTICAL DIVISION– Baltimore, MD

(formerly Barre National, Inc.)

Quality Assurance Manager– 03/1991 to 04/1999

Held a series of management positions within the Quality organization where deficient systems were in need of re-configuration for improved efficiency and compliance.

Manager Printed Materials 01/1996 – 04/1999

Key Results:

Designed and developed a new system resulting in labeling compliance; decreased cycle time and increased service levels; managed the conversion of labeling (550 jobs) due to transfer of manufacturing to alternate facility resulting in $10M cost reduction; managed the conversion of labeling (1,500 jobs) due to company name change.

Manager, IQA/Label Issuance 03/1994 to 01/1996

Managed inspection of raw materials and components; control and issuance of labeling to Operations.

Key Results:

Developed compliant sampling plans, inspection specifications and test methods, automated data entry and SPC; developed Vendor Qualification Program; established two-shift operation in IQA and three-shift operation in Label Issuance through efficiency improvements.

Compliance Manager 03/1991 to 03/1994

Internal and external compliance auditing; management of external inspections by regulatory agencies and customers.

Key Results:

Established internal audit program resulting in CGMP system development; established partnerships with customers and regulatory agencies.

BIOCLINICAL SYSTEMS – Columbia, MD –

Quality Manager - 10/1988 to 03/1991

Managed all Quality, regulatory and technical functions of the manufacture of microbiological products for the physician’s office laboratory.

Key Results:

Designed, planned and organized a new clean room facility; developed and implemented an internal calibration and validation program resulting in cost reduction; performed validation of terminal sterilization and aseptic filling processes; established Technical Services Department resulting in customer training and satisfaction.

Experience prior to 1988:

Becton Dickinson Microbiology Systems - New Product Engineer/Quality Control Supervisor

Education

THE PENNSYLVANIA STATE UNIVERISTY State College, PA

B.S. in Microbiology with a Minor in Chemistry

COMPUTER SKILLS:

Microsoft Office, developed Label Tracking System in Access

SUMMARY OF EXPERIENCE WITH REGULATORY AGENCIES

MEDICAL DEVICES:

Becton Dickinson Microbiology Systems, Cockeysville, MD

Performed in-house testing of antibiotic susceptibility test discs for certification in use of Kirby Bauer testing; submitted lots to FDA for certification; and performed parallel testing at FDA laboratories in an effort to establish equivalency and waive certification.

Compiled, submitted and resolved comments to FDA 510(k) applications for new device products.

Planned, equipped and trained personnel for chemical and microbiological laboratories in new off-shore (Puerto Rico) facility resulting in no 483 observations during FDA inspection.

Bioclinical Systems, Columbia, MD

Hosted FDA biennial inspection resulting in no 483 observations.

DRUGS (GENERIC CREAMS, OINTMENTS, LIQUIDS, AND MDIs):

Alpharma, U.S. Pharmaceutical Division, Baltimore, MD

Hosted DEA inspections resulting in no citations; coordinated ARCOS reporting and CDS destructions with DEA personnel.

Hosted FDA inspections resulting in Warning Letter and subsequent meetings resulting in Consent Decree. Established relationship with third party auditor and FDA in order to terminate Consent Decree.

DRUGS AND API, ORAL SOLID DOSAGE FORMS:

Atlantic Pharmaceutical Services, Inc., Owings Mills, MD

Successful pre-approval inspections from US FDA and EU.

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