Manufacturing Quality Assurance

Richard Adkins

***** ***** ****, ******, ** ***** - 423-***-**** - ******@*****.***

Career Profile

An energetic, highly motivated management professional with proven

experience in manufacturing, process development and quality areas.

Achieves goals through effective communication and teamwork. Functions

effectively in a fast paced, results oriented environment. Builds strong

teams using creativity, inspiration, and a positive attitude. Applies

honesty and integrity to all aspects of the business.

Recent Accomplishments

. Spearheaded lean process initiatives and continuous improvement plans

to increase capacity 10 - 15%.

. Developed training workshops to help employees decrease human error

deviations by 20%.

. Engaged personnel in 5S techniques for continuous process improvement

on unit operations.

. Built a core manufacturing management team across 2 shifts.

. Coordinated communication meetings between shift supervisors.

. Established employee job descriptions and career progression plans to

motivate and promote employee growth.

. Created On-Job-Training Certification Program to develop employee

talent and skill sets.

. Implemented on-going accountability and RTFT initiatives for

manufacturing and cGMP processes.

. Established KPIs to measure customer service, scheduling and safety

using monthly scorecards.

. Implemented a Total Productive Maintenance (TPM) program to improve

poor process cycle efficiency.

Professional Experience

CADISTA PHARMACEUTICALS, INC. - Salisbury, MD

January 2010 - May 2013

Director, Manufacturing/Packaging Operations

. Directed manufacturing/packaging of 3 shift solid dose operations of

80 direct and indirect labor personnel

. Established capacity and production requirements based on monthly

schedules.

. Championed and supported lean initiatives to improve productivity of

operations through business excellence incentives.

. Interacted with QA and support groups to resolve technical and GMP

issues.

. Directed OEE of all production equipment to maximize efficiency of

functional areas and minimize downtime.

. Managed cross-functional teams to derive root cause analysis and

resolutions for deviations, investigations and CAPA's.

. Developed competency based training requirements for manufacturing

personnel through OJT certification.

. Assisted HR in establishing position and pay scale matrices for

manufacturing and packaging unit operations.

. Managed the implementation of the SAP inventory system for the

manufacturing and packaging areas.

PHARMACEUTICS INTERNATIONAL, INC. - Hunt Valley, MD

December 2008 - January 2010

Director, Manufacturing/Packaging Operations

. Directed and coordinated manufacturing for clinical trial and

commercial operations.

. Interacted with business management in the introduction of new

products and processes.

. Managed capacity and production requirements based on monthly

schedules.

. Developed and lead initiatives to improve productivity of operations.

. Interacted with clients and vendors weekly to coordinate project

timelines.

. Established and maintained monthly KPIs to accurately measure

commercial manufacturing units.

. Provided continuous improvement in low performing areas.

. Participated with QA to establish root cause analysis and resolutions

for process deviations, investigations and CAPA's.

Richard Adkins

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Shire Pharmaceuticals, Inc. - Owings Mills, MD

April 2007 - September 2008

Director, Manufacturing

. Managed direct labor of 105 personnel to manufacture solid dosage

products.

. Maintained an annual budget of $9.0 million.

. Handled recruitment and management of manufacturing personnel.

. Ensured safety, training and quality metrics for all manufacturing

operations.

. Supported product transfer from third party contractors according to

SUPAC guidelines.

. Reported monthly metrics for customer service, product cycle time and

labor efficiency.

. Interacted with QA and other support groups to resolve technical and

GMP issues in manufacturing.

. Assisted in reorganizational structure of business units through value

added lean initiatives.

. Teamed with the Microbiology department to create an environmental

cleaning program for the manufacturing area.

King Pharmaceuticals, Inc. - Bristol, TN

October 1998 - March 2007

Director, Manufacturing 2003 - 2007

. Directed manufacturing and packaging operations of solid dose, semi-

solids and inventory management using SAP.

. Interacted with Engineering and Quality Assurance to resolve technical

issues in manufacturing through change control.

. Assisted Pharmaceutical Technology on product transfer from third

party contractors according to SUPAC guidelines.

. Revised master batch records for existing products and originated

master records for solid dose products.

. Assisted in the design and layout of new manufacturing suites within

Solid Dosage area.

. Assisted in the performance of factory acceptance tests for new and

refurbished equipment in Solid Dosage area.

. Managed annual budget of $4.9 million.

. Utilized six sigma techniques to resolve deviation metrics for solid

dosage activities.

. Implemented a Total Productive Maintenance (TPM) program in

collaboration with Maintenance/Engineering to achieve maximum OEE of

solid dose unit operations.

. Ensured monthly production schedule adherence metrics.

. Measured labor capacities to ensure monthly maximum efficiencies.

. Conducted technical, cGMP, safety and compliance training sessions for

manufacturing employees.

. Reported quarterly status to senior management for Manufacturing

Operations.

Manager, Solid Dose Manufacturing 1998 - 2003

. Managed process equipment and implemented manufacturing process

improvements for solid dose manufacturing.

. Revised existing and generated new SOPs for processing equipment.

. Lead hands-on process training for all manufacturing personnel.

. Revised master batch records for solid dose products.

. Reviewed and approved manufacturing IQ, OQ and PQ validation

protocols.

. Conducted annual performance evaluations and merit reviews for

personnel.

Granutec Pharmaceuticals, Inc. - Wilson, NC

January 1998 - October 1998

Manager, Quality Assurance

. Performed cGMP internal and external audits for contract

manufacturers, vendors and suppliers.

. Performed cGMP training for all QA personnel.

. Maintained documentation for cGMP compliance.

. Approved new and existing product master records and process

validation protocols.

. Developed SOP's associated with in-process and finished product

manufacturing control of solid dosage forms.

. Directed and managed Quality Assurance functions for 7 Quality

Assurance Auditors.

. Developed QA deviation system that interacted with QC, Validation,

R&D, Compliance, and Production.

. Monitored batch record production data (SPC) trend analysis within

cGMP compliance.

. Established appropriate cycle times necessary for the timely release

of a quality product.

. Assisted QA/QC for cGMP Compliance, FDA correspondence,

investigations, audits, pre-approval, and cGMP Inspections.

Richard Adkins

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Kenmont Laboratories/Sovereign Pharmaceuticals - Ft. Worth, TX

1995 - 1997

Manager, Manufacturing Operations/Compliance Training 1996 - 1997

. Managed manufacturing operations of solid dosage forms and liquid

manufacturing.

. Reviewed manufacturing processes and implemented process changes.

. Completed process deviations and revised product master records.

. Reviewed finished product batch records for accuracy and GMP

compliance.

. Reviewed IQ and OQ Protocols for all major processing equipment.

. Conducted periodic GMP training for manufacturing.

Manager, Compliance Training 1995 - 1996

. Established and maintained on-going cGMP and SOP training program for

solid dose and liquid manufacturing.

. Periodically performed internal audits to ensure GMP and SOP

compliance.

Boots/Knoll Pharmaceuticals, Inc. (currently Dr Reddys) - Shreveport, LA

1982 - 1995

Supervisor, Process Development 1992 - 1995

. Supervised the manufacture of clinical supplies with formulation

technicians.

. Coordinated process development and clinical supply activities using

Microsoft Projects.

. Implemented SOPs for process development.

. Periodically trained formulation technicians on processing equipment.

. Assisted in the implementation of IQ's and OQ's of pilot plant

equipment.

Senior Research Technician 1987 - 1992

Research Technician 1986 - 1987

Manufacturing Operator III 1983 - 1986

Shipping Clerk 1982 - 1983

LuChem Pharmaceuticals, Shreveport, LA

1980 - 1982

Production Supervisor

Educational/Professional Development

B.S. Organizational Management, Tusculum University, Greenville, TN

Professional Training:

Lean and Culture Training Workshop

The Five Dysfunctions of a Team Workshop

Overview of Lean Manufacturing & Six Sigma

Lessons in Leadership: Building Bridges to the Future

Attended numerous workshops and seminars related to technical processes,

leadership and quality skills within the pharmaceutical industry. (23 CEU

hrs.)

Sponsored and championed Lean Manufacturing Initiative Projects

In the process of obtaining Six Sigma Green Belt Certification

Contact this candidate