BARBARA BAKER17574 W. Nighthawk Way Goodyear, AZ 85338 (623) 266-2544 H (443) 386-3892 C 0825bab@gmail.com

QUALITY ASSURANCE PROFESSIONALAREAS OF EMPHASIS – CLINICAL LABORATORY, MANUFACTURING, RESEARCH AND

DEVELOPMENT

Quality Assurance professional with broad experience, seeking a new opportunity. Extensive experience ensuring quality in regulated manufacturing and research & development environments for pharmaceutical, over-the-counter, and cosmetic products. Well-developed skills auditing the quality of contract manufacturers, suppliers, and contract laboratories and working with regulatory agencies such as the FDA, ANVISA, and MHRA. Expertise and knowledge of CLIA 88 Regulations for Public Health Laboratory quality system management. Excellent organization and communication skills with a reputation for multitasking and solving problems in fast-paced environments.

Areas of ExpertiseCLIA 88 Regulations | Good Manufacturing Processes (cGMP) | Quality Assurance Systems Management | Risk

Mitigation | Quality System Auditing | Quality Systems Validation |Quality System Training | Material & Product Approvals

EXPERIENCEArizona Dept. of Health Services, Office of Laboratory Services, Phoenix AZ Sept. 2012 - PresentADHS Microbiology Lab Quality Assurance Officer Quality system management of CLIA 88 regulated Bacteriology, Virology, Serology, and Bio Emergency

Laboratories. Review of laboratory monthly QA reports, corrective actions, Proficiency Test and Internal Accuracy results. Review of testing procedures for CLIA 88 compliance and writing of standard operating procedures. Perform investigations of significant issues identified by internal audits, complaints or internal QA reviews. Lead and manage the internal laboratory QA audit program Perform other duties as assigned (i.e. Laboratory ISO/IEC 17025 accreditation preparation; Document Control

System creation and management.)

Key Accomplishments Mastery of QA leadership role, duties, knowledge of clinical methods and CLIA 88 Regulations (< 3 months).

Teva Pharmaceuticals, AZ (former Procter and Gamble contract manufacturer) Nov. 2011 - Jun. 2012 Quality Control Lab Supervisor Managed and oversaw the quality of Procter & Gamble’s Metamucil brand manufacturing including 14

permanent and temporary employees. Performed general lab supervisory duties of analytical, microbiology and incoming laboratory technicians. Oversaw laboratory testing services including raw material, in-process and final product sampling and testing

of the Metamucil Brand. Led laboratory investigations for material, in-process, and finished product out of specification investigations. Managed raw material full testing program with contract laboratory testing.

Key Accomplishments Co-managed various quality assurance management responsibilities for 3 months during the transition from

Procter & Gamble to Teva Pharmaceuticals until the Teva Site Quality Assurance manager was hired; performed procedure approvals, site system validation approvals, out of specification investigation approvals and provided daily coaching to the manufacturing staff regarding material and product quality issues.

Instrumental in leading the execution of the QA/QC team structure changes after Teva Pharmaceuticals took ownership of the manufacturing facility.

Managed the revision of the raw material analytical testing program; moved 16 raw materials from reduced testing to full testing of internal, USP and EP analytical testing methods.

Quality Control Lab Supervisor, Procter & Gamble Household Care Division, AZ Feb. 2011 - Nov. 2011 Managed the overall quality and compliance of the lab used to manufacture Metamucil, a drug and dietary product, globally. Managed and oversaw the quality of analytical and microbiology systems and laboratories. Assisted in managing and improving the analytical and microbial risk mitigation systems within the plant to

ensure product quality. Managed plant lab resources and performed quality training for staff members. Performed troubleshooting, led lab investigations, identified and implemented corrective actions to mitigate

risk and ensure product quality.

Key Accomplishments Member of the Site QA Audit Host Team for regulatory agency audits; quality team hosted FDA, MHRA, and

ANVISA site inspections with no 483’s or critical observation sited. Spearheaded a lab renovation project; purchased new equipment and managed the completion of equipment

validation packages. Active member of the Purified Water System Validation Team; provided coaching on quality testing

requirements for IQ/OQ and PQ validation of the system. Reviewed site microbiology monitoring systems; developed, tracked and confirmed alert and action limits.

Quality Assurance Manager – Procter & Gamble Beauty Care Division, MD Jan. 2000 - Feb. 2011 Provided quality support for 80 research and development team members during the product development

phase of color cosmetics products and product turnover to manufacturing for production. Performed quality assurance audits of contract manufacturers, contract laboratories and material suppliers. Performed quality approval of consumer studies, material qualifications, accelerated stability reports, and

standard operating procedures. Led quality training for the organization. Facilitated Research and Development and Manufacturing personnel with design related product issues and

consumer complaints investigations.

Key Accomplishments Facilitated and led local and global research and development meetings to support the resolution of product

initiative start-up issues as well as issues with products on the market. Led the R&D through the development and implementation of a new quality system tool (DQIe2e). The new

system was used to manage product quality on major initiatives. Facilitated and secured funding for the R&D department to convert to the global Newton web-based Quality,

Job and Safety Training database; led a team to create, data load, and train the department.

Quality Assurance Microbiology Laboratory & GMP Systems Team Manager, Procter & Gamble Beauty Care Division (Jan. 1991 – Jan. 2000)

EDUCATION & ADDITIONAL TRAININGCornell University, Ithaca, NY, Bachelor of Science Degree in Biology

ISO/IEC 17025 Accreditation, San Diego, CA April 2013

COMPUTER SKILLSMicrosoft Word, Excel, PowerPoint, Outlook, Visio, Track Wise, LIMS, SharePoint and web-based applications