Quality Control Assurance
Resume:
Fairfield, NJ *****
Phone: (***) 477 - 9262
Email: ******@****.***
Samantha Leigh
Chemist II, Laboratory Technical Services,
CorePharma LLC
Professional Profile:
I am a three-year pharmaceutical professional with a broad range of
laboratory experience and project management in relation to compliance,
development, quality, qualification and validation experience within the
pharmaceutical industry. Experience with oral dosage forms. Experience in
both quality and R&D environments with thorough knowledge of applicable
aspects of cGMPs, GLPs, GDPs, QBD, and FDA/ICH guidances and
requirements. I am knowledgeable of industry standards and regulatory
expectations in relation to investigations, CAPAs, method validation, and
quality systems. Experience with cGMP audits, interaction with FDA
personnel, corrective action planning / plan execution, change control, and
many other Quality Unit requirements.
I have applied my skills towards various company objectives, quality
programs, new product development and compliance remediation. Some
projects include:
• Development or remediation of quality systems
• Development of technology transfer systems in support of new
product launch
• Implementation of corrective action plans
• Development, validation and transfer of Laser Diffraction Particle
Size Methods
• Remediation of the Reference Standard Program
• Remediation/creation of the Compendia Compliance Program
• Analytical Method Master Plan
• Development of product specifications in conformance to USP
requirements
• Maintenance of the Stability Program
• Development and training of staff
• Change control process
• Cost reduction and laboratory efficiency
I have been a part of a company that has successfully remediated a FDA
warning letter in which I was responsible for various remediation activities
and part of a remediation team.
Professional Summary
Experience:
Chemist II, Laboratory Technical Services
CorePharma LLC
Chemist I, Laboratory Technical Services
CorePharma LLC
Education:
B.A. Biological Sciences – Minor Sociology
University of Delaware
Key areas of expertise include:
• Outside Testing Facility Management
• GMP/PAI Inspection Readiness
• Quality Systems and Compliance Remediation
• Project Management
• Process Improvements / Change Control
• Validation and Technology Transfer
• Preparation of release testing specifications and control limits of
raw materials, in process materials and finished products
• SOP Development/Implementation
• Compendia Compliance
• Stability
• Reference Standard Qualification
• Laboratory Investigation/Deviation/Non-Conformance
Investigation
Computer Skills:
Proficiency in Microsoft Word, Excel, Access, PowerPoint, and Adobe
Photoshop
Experienced in Malvern Matersizer 2000, TotalChrom, WinLabs, Master
Control, SAP, and SLIM Software.
Samantha Leigh
2 Midvale Avenue, Fairfield, NJ 07004
(973) 477 - 9262
Email: ******@****.***
SUMMARY:
Pharmaceutical professional with 3 years of GMP environment experience, including an extensive compliance
remediation background.
WORK
EXPERIENCE:
October 2010 - Present CorePharma LLC Middlesex, NJ
November 2011 - Present
Chemist II, Laboratory Technical Services
Responsible for regulatory inspection readiness and served as subject matter expert for the Quality Control
Reference Standard Program.
Served as the backup scribe for the FDA Audit.
Executed integrated project plans to ensure timely completion of quality system compliance commitments
during successful FDA Warning Letter remediation.
Proposed USP/In-house Reference Standard budget in compliance with company overall cost reduction initiative
Continued improvements in the Compendia Compliance program. Responsible for completing compendia
review of all Active Pharmaceutical Ingredients and Excipients.
Managed Compendia Compliance Program and coordinated with third-party site to initiate equivalency analysis
of In-house methods and Compendia methods.
Reviewed protocols and reports prepared by third-party site, regarding Compendia Crossover analysis.
Responsible for all reference standard materials supporting all laboratories, including reference standard
qualification, maintenance, and tracking of reference standards.
Performed Role as Stability Coordinator.
Development, validation, and method transfer of Analytical Testing Methods for drug substances.
Review of SOPs, test methods, and protocols to support method validation.
Implementation of Standard Operating Procedures in accordance with Company Policies and regulatory
commitments.
Development and implementation of new analytical techniques and methodology.
Analytical method validation and technology transfer under cGMP guidelines.
Training, mentoring, and coordination of junior staff.
Conducted Out of Trend, Deviation and Out of Specification investigations
Responsible for identifying, initiating and closing CAPA’s as identified in investigations.
Investigation of Laboratory Events and management of CAPAs for commercial projects.
Created and managed the Laboratory Safety Committee to enforce proper safety within the Quality Control/LTS
Laboratories.
Assisted in method transfer for New Product Launches.
Aided in non-routine testing to support manufacturing including physical and chemical characterizations.
October 2010-November 2011
Chemist I, Laboratory Technical Service
Entry-level chemist in Laboratory Technical Services Laboratory which functionally supports Quality Control,
Analytical Development, Quality Assurance, and Production.
Team member to remediate laboratory quality systems to comply with regulatory commitments.
Responsible for all reference standard materials supporting all laboratories, including creation of a reference
standard qualification program and tracking system of reference standards.
Performed role of Subject Matter Expert of Reference Standard Program during regulatory inspections.
Created the Compendia Compliance Program. Coordinated/managed the review and implementation of
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Compendia changes for all compendia products and raw materials through Compendia CAPA.
Coordinated with third-party site to initiate crossover analysis of In-house methods and Compendia methods.
Reviewed protocols and reports prepared by third-party site, regarding Compendia crossover analysis.
Coordinated with third-party site to initiate additional testing of in-house methods that did not meet set
acceptance criteria. Testing was done to prove that In-house methods are better than the Compendia methods.
Performed as a back up to the Stability Coordinator to allow for uninterrupted stability program operation.
Reviewed and trended on a quarterly basis, all Laboratory Investigation/Laboratory Event reports.
Execution of in-house identification to support production and quality assurance in foreign matter investigations.
Reviewer of methods, technical reports, and data.
Development and implementation of new analytical techniques and methodology.
Validation and transfer of analytical methods.
Author and review of quality systems and SOPs.
Review of SOPs, test methods, and protocols to support method validation.
Review of Laboratory notebooks.
Supported Particle Size testing. Creation or proposed particle size specifications for API.
Trained personnel on new or updated SOPs and Analytical Methods. Developed Lesson Plans where required for
training purposes.
Laboratory/Safety Improvements.
FDA audit support.
Conduct and closure of CAPAs/LIRs/MERs in support of other departments.
Increased efficiencies by method development of efficient analytical methods, and qualification of in-house
reference standard material to reduce required operating budget of the Quality Control Laboratory
Purchased materials required for the laboratory and opened Purchase Requisitions for outside testing to support
non-routine testing using SAP.
June 2009 – August 2009 Aqua ProTech Laboratories Fairfield, NJ
Intern, Microbiology Laboratory
• Performed BOD testing on water samples.
• Performed microbiological testing, i.e. E. coli levels in pools, lakes, hot tubs, and drinking water.
• Worked independently for 2 months of the internship.
EDUCATION: 2006–2010 University of Delaware Newark, DE
B.A., Biological Sciences
Minor - Sociology
Technical
SKILLS:
• Particle Size by Laser Diffraction
• HPLC
• Dissolution
• pH
• BOD Analysis
• Microbiological Plating
• USP, EP, BP, and JP testing methods
• TotalChrom, SLIM, SAP, WinLabs, Master Control and Malvern Mastersizer 2000 Software
• Microsoft Excel, Word, Access, PowerPoint, and Adobe Photoshop
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