Quality Assurance Control
Resume:
Daniel G. Carlson
Greenwood, SC 29649
Mobile: 919-***-****
Objective: Seeking a challenging position where my experiences and education will
prove beneficial. Open communication and building a strong goal oriented team
environment are two of my attributes.
SUMMARY
14 + years Supervisory Experience in Pharmaceutical and Medical Device
Manufacturing – (11 years with Abbott Laboratories/Hospira Inc.)
14 years FDA, GxP regulated environment (including Aseptic and Terminal
Sterilization filling environments)
11 years Quality Assurance experience
7 years DEA environment (class II, III, & V controlled substances)
6 years chemistry laboratory experience
3 years EPA regulated environment
3 years ISO 9000 regulated environment
Attained Six Sigma Greenbelt Certification (2006)
Bachelor Of Arts Biology, Elon College, 1992
WORK EXPERIENCE
December 2007 – Jan.2009: Covidien –Greenwood, SC
Quality Engineer
Validations, Raw Material Qualifications,
Internal Audits, Process Capability, FMEA
March 2006 – Dec. 2007: Hospira Inc. – Rocky Mount, NC
Senior Supervisor MQ Operations Supervisor
Responsibility for MQ Operations in FLEX,
Large Volume Parenterals, continue supporting
Small Volume Parenterals, Part Fill Flexible
Container line Implementation, Cost Reduction
team leader for Manufacturing Quality
April 2004 – March 2006: Hospira Inc. – Rocky Mount, NC
Manufacturing Management Acceleration Program
April 2004 – Sept. 2004 Small Volume Parenteral Finishing Supervisor
Oct. 2004 – March 2005 Flex Print on Fabricator Supervisor
April 2005 – Sept. 2005 Small Volume Parenteral TS (Terminal
Steralization) Supervisor
Oct 2005 – March 2006 MQ Operations Supervisor
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Daniel G. Carlson
Dec. 2000 – March 2004: Abbott Laboratories – Rocky Mount, NC
Manufacturing Quality Assurance Supervisor
Oversee Quality Assurance activities and Quality Control
& Audit personnel; assure timely completion of all
performance appraisals/counselings; final product batch
record release, assure all products are manufactured in
conformance with Abbott, cGMP, DEA & FDA
regulations; perform routine facility audits; planned
errors; communicate directly with Manufacturing
management, regulatory, Engineering, Maintenance,
division Q.A., and Abbott International personnel;
write and modify exception documentation, plant
documents, SOPs, & specifications.
Jan. 2000 – Dec. 2000: Abbott Laboratories – Rocky Mount, NC
Chemical Quality Assurance Supervisor:
Oversee off-shift CQA activities and personnel; audit all
Chemistry batch records; communicate directly with
Quality Assurance and Production personnel (solutions
and filling); write or modify pertinent SOPs,
Specifications; develop protocols for problem
solutions; communicate with division R&D; assure
laboratory and all testing are performed within
company specifications, GLP, and FDA compliance.
May 1996 – Jan. 2000: Abbott Laboratories – Laurinburg, NC
Manufacturing Quality Assurance Supervision
Responsible for off-shift Quality Assurance activities
Assure all products are manufactured in conformance with
Abbott, GMP, and ISO 9000 regulatory compliance;
Update, process map, and implement necessary plant and
company documents and specifications; direct quality
system auditors; communicate directly with production
management, engineering, maintenance, division quality
assurance
Oct. 1994 – May 1996: Novel Pharmaceutical, Inc. – Hamlet, NC
Quality Control/Laboratory Supervisor
manufacture, packaging and release of all Povidone
Iodine based products per USP requirements
(solutions, surgical scrubs, nonaerosol sprays,
perineal wash, douche, swab pads and sticks, gauze
pads, and ointments); supervise quality control floor
personnel, product packaging, and plant cleanliness;
performed chemical and microbiological testing for all
in-process and final product, new products; writing
pertinent standard operating procedures.
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Daniel G. Carlson
May 1992 – Sept. 1994: Burlington Research, Inc. – Burlington, NC
Chemical Analyst: prepare and analyze environmental
(soil, influent and effluent industrial samples) using wet
chemistry, gas chromatography, and mass sprectrometry.
EDUCATION
Bachelor of Arts – May 1992
Elon College – Elon College, NC
Major: Biology
Other Emphasis: Chemistry (16 hours, including 2 semesters of Organic)
Study Abroad: Spring Semester 1989 (London)
Independent Studies:Taxonomic Study of Ant Fauna of Alamance County,
NC, Fall1989 through Spring 1991;
A Protein Comparison of Various Ant Species using
Polyacrilamide Gel Electrophoresis, Spring 1992
AFFILIATIONS/VOLUNTEERISM
January 2009 – Present: Self Regional Healthcare Volunteer (Greenwood, SC)
Sept. 2008 – Present: American Society for Quality Member (Lakelands, SC chapter)
Oct. 1997 – Sept. 1998: American Society for Quality Member (Sandhills, NC chapter)
Oct. 1994 – May 1996: Scotland County School System – Laurinburg, NC
Substitute Teacher (Fridays only)
May 1993 – December 1995: American Chemical Society Member
April 1991 – Present: Omicron Delta Kappa (Leadership Honor Society) Member
COMPUTER SKILLS
Microsoft Word
Microsoft Works
Access (Created databases for Hospira TS filling operations
and MQ Operations Employee Error tracking)
Excel
Powerpoint
Lotus Notes
WordPerfect Office 2002
Microsoft Visio
Minitab version 14 & 15
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Daniel G. Carlson
ADDITIONAL TRAINING
Internal Auditor Training (Covidien Augusta, GA Plant, January 2009)
Corrective Action & Preventive Action Training (Covidien Greenwood, SC
Plant December 2008)
Six-Sigma Greenbelt Certification with Minitab (Edgecombe Community
College, NC, September 2006)
Supervisory and Management Skills for the 21 Century (Rocky Mount,
st
NC, October 2004)
Managing Conflict (Nash Community College, NC, February 2004)
Coaching Skills: Abbott Labs (Rocky Mount, NC, August, 2000)
Applied Statistics: Abbott Quality College (Chicago, IL, January, 1998)
Design of Experiments for Injection Molding (Laurinburg, NC, March, 1998)
Behavioral Patterns (Laurinburg, NC, June, 1998)
Decision Making (Laurinburg, NC, February, 1999)
Performance Management (Laurinburg, NC, April, 1999)
Fisher Scientific Instrument and Seminar Exposition (Raleigh, NC, Oct.
1995)
Effective Teacher Training (Richmond Community College, Fall 1995)
J & W Gas Chromatography Short Course (NCSU, May 1994)
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