Quality Assurance Control

Nicole Schiller

Profile:

Accomplished QA/QC/cGMP Compliance professional with over 15 years of progressive experience and proven record of significant,

successful contribution in Quality Assurance, Quality Control, Quality Systems, Auditing, cGMP Analytical Laboratory Remediation

activities, Process Improvement, Analytical Data Review, documentation requirements, and CAPAs.

Areas of Expertise:

Quality Assurance and Quality Control CAPAs, NCMRs, Investigations, Deviations, Change

Control

FDA cGMP & Part 11 Compliance Analytical Method Development/Validation

Quality Systems Batch Record Review

Regulatory Compliance HPLC and ICP methods

Research and Development Analytical Data Review

Project Management Internal, Customer and Laboratory Audits

Quality Control/ Laboratory Experience :

Managed pharmaceutical quality control laboratory with chemistry and microbiology departments.

Executed chemistry testing on raw materials, bulk, and finished products using methods including GC (Agilent 5890 and 6890),

HPLC (Waters), IR (Nicolet), TLC, UV, and wet chemistry to USP/NF, EP, BP, and JP standards

Performed method validation and interlaboratory qualifications (ILQ) for method transfer

Technically wrote and reviewed Standard Operating Procedures (SOP’s) to support the quality function with the guidelines of

the GMP and analytical department

Reviewed and approved colleagues’ data and laboratory notebooks analytical data in a controlled documented electronic system

(LIMS), analytical methods, SOP’s for accuracy and completeness for compliance in accordance to company procedures and

regulatory guidelines

Maintained stability program and performed stability testing per ICH and FDA guidelines

Ensured compliance, quality, data integrity and method verification/ validation of laboratory activities in support of

manufacturing to ensure testing and release of clinical and commercial batches

Assisted in setting up General Analytical Chemistry laboratory to increase sample throughput

QC validation, protocol, and data review

Created laboratory systems for every aspect of the laboratory to ensure compliance, documentation, and change control

Reviewed, analyzed and trended analytical data that was result of investigational reports, procedural deviations, and OOS

investigations.

Responsible for company’s commercial product stability testing program

Expanded laboratory capabilities by integrating new instrumentation and methodologies, as well as implementing research and

development and method development and validation functions

Instrumental in establishing the laboratory as a stand-alone profit center for the company

Participated as a cross functional team member with Quality Unit and Analytical R&D group to review and recommended

changes to laboratory investigational, procedural deviations, and change control reports for analytical methods and equipment

within the guidelines of GMP and ICH through the lifecycle of the products

Quality Assurance Experience:

Experience with solid oral dosage, semi-solids, liquids, and sterile finished fill manufacturing

Providing guidance to ensure cGMP compliance in response to FDA 483

Performed Internal and external audits (CMOs, Contract laboratories, Suppliers) including planning (scope and agenda),

preparation checklists) performance/conduct, identification of nonconformities and the compliance risk level, reports, corrective

actions follow up, and timely closures of corrective actions and audit reports.

Investigated and responded to customer complaints

Writing and completing CAPA reports, Nonconformance reports (NCMRs), Change control EOs.

Investigations of CAPAs, Nonconformance’s, Deviations, and product Complaints including root cause analysis,

corrective/preventive actions proposal, implementation, effectiveness verifications, and timely closures using quality problem

solving and process improvement tools.

Deviation reports and investigations, risk assessment, CAPA, Empower project administration/management, quality system

procedures, and change control.

Batch Record Review

Wrote and revised Standard Operating Procedures (SOPs) and master batch records

QA validation, protocol, and data review

Validation and Implementation teams for QMS systems

Developed Certificate of Analysis program

Facilitated technical transfer of new projects through interface with Research & Development, Sales & Marketing, Operations,

and Logistics

Instituted cGMP compliant environment for Quality Systems to support new FDA regulations for the Dietary Supplement

industry Development, implementation, maintenance and management of quality systems

Ensured technical service revenue were met by identifying and tracking protocol billing deliverables

Oversaw environmental quality assurance program throughout the laboratory

Facilitated state, client, and third-party audits, including responses and corrective actions

Supported sales organization and project management team

Managed environmental proficiency testing program

Performed quality product investigations and complaint evaluations on drug products

Assisted in implementing system of documentation required for class II medical device design history files

Completed annual drug product reviews for submission to FDA

Professional History:

QC Chemist- QA/QC Investigations 2012 Gilead/Alcon/Oxford International, Foster City, California

Quality Control Manager 2010 – 2012 Third Coast Terminals, Pearland, Texas

Quality Assurance Officer 2008 – 2010 Accutest, Houston, Texas

Quality Assurance Manager 2005 – 2008 Biotics Research Corp., Rosenberg, Texas

Quality Control Manager 2003 - 2004 Elge, Rosenberg, Texas

Quality Systems Project Manager 2003 DPT Laboratories, San Antonio, Texas

Quality Control Supervisor 2000 – 2003 DPT Laboratories, San Antonio, Texas

Quality Assurance Product Standards Analyst 1999 – 2000 DPT Laboratories, San Antonio, Texas

Quality Control Scientist 1996 – 1999 DPT Laboratories, San Antonio, Texas

Technical Marketing Representative, 1991 – 1994 Abbott Laboratories Los Angeles, California

Clinical Chemistry Systems Specialist 1989 – 1991 Abbott Laboratories, Irving, Texas

Medical Laboratory Technician, 1988 – 1989 Parkland Hospital, Dallas, Texas

EDUCATION

B.S. Degree, Chemistry, 1988 University of Mary Hardin-Baylor, Belton, Texas

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