Quality Manager

Donna Domingo

Email: abo4hv@r.postjobfree.com

Address: ** ***** ****

City: Monroe Township

State: NJ

Zip: 08831

Country: USA

Phone: 914-***-****

Skill Level: Management

Salary Range: 90

Primary Skills/Experience:

See Resume

Educational Background:

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Job History / Details:

Accomplished, efficiency-minded senior-level Documentation/QA Management Professional with more than 15 years of experience leading change control, training, methods/specifications, and protocol review/approval for the pharmaceutical and commercial food industries. Strong multi-tasker with excellent organizational and leadership skills; highly capable of managing multiple, large-scale projects and supervising diverse, cross-functional teams to on-time, on-budget project completion. Detail-oriented with acute understanding of industry standards and regulations compliance. Quickly assesses systems/processes to identify areas for improvement and cost control; holds record of accelerating processing times and saving hundreds of thousands of dollars with zero loss in quality. Extremely motivated problem solver, readily takes on new and difficult challenges, demonstrating stellar commitment and performance in fast-paced work environments.

SELECT CAREER ACCOMPLISHMENTS

Decreased change control processing time to 50% by working with the IT department to complete second phase development of an electronic change control system.

Increased commercial batch release to market 35% by evaluating the batch review/audit process, eliminating redundancies, and keeping the system within compliance.

Provided compliant documentation to the FDA, resulting in a January 2012 FDA general inspection without a 483 write-up.

Developed an APR system (existing APR was insufficient by industry standards) and revised the company standard operating procedure (SOP) process to meet cGMP requirements.

Returned the company to VAI status through remediation with the FDA by creating and implementing a training system.

Avoided costly FDA observations by developing a company-wide comprehensive training system and individual curriculums.

Commissioned, validated, and administered an electronic APR system that functioned in real time and was utilized by all respective departments to enter data and ensure data integrity.

Contributed to company savings of >$300K by leading and completing the development of a compliant change control system and process flow.

Maintained the position of Documentation Specialist/APR Coordinator and was later offered a position of Regulatory Compliance Associate following company acquisition.

PROFESSIONAL EXPERIENCE

Senior Manager of Quality Systems, G&W Laboratories 2011 to 2012

Developed a company wide comprehensive document retention system/process, to maintain compliant document control. Collaborated with Quality Compliance in identifying root cause of deviations (i.e. OOS, OOT, Environmental and Equipment deviations etc.), assisted in CAPA evaluations, assignment and investigation closure, which significantly decreased investigation closure turnaround time. Created and maintained a Quality Manual. Led weekly QRB meetings to provide cross-departmental assessments/resolutions of quality issues that impacted product or processes.

QA Manager of Document Control, G&W Laboratories 2009 to 2011

Drove quality related decisions, with appropriate approval authority (both data-based and risk-assessment-based decisions) to maintain quality compliance. Created a compliant Methods and Specifications versioning system (raw materials, finished product, stability, and components) to assure unambiguous acceptance criteria/requirements. Developed, supported, and maintained departmental SOPs and Quality System processes, as required, ensuring robust and complaint processes across the company. Developed and maintained robust APR (Annual Product Review) reports. Performed company-wide cGMP training and training on core Operational and Quality SOPs. Developed a comprehensive company-wide training system, assisted area management in creating individual curriculum, and implemented curriculums within the developed database.

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Donna Domingo

35 Leeds Lane, Monroe Township, NJ 08831 ~ Primary: 888-***-**** ~ Alternate: 914-***-**** ~ abo4hv@r.postjobfree.com

PROFESSIONAL EXPERIENCE, CONTINUED

Regulatory Compliance Associate, TEVA/BARR/PLIVA Inc. Pharmaceuticals 2008 to 2009

Compiled non-conformance trending reports, vendor qualification reports for all TEVA raw materials, and Annual Product Review (APR) for all residual Barr/Pliva products.

Document Control/APR Coordinator, TEVA/BARR/PLIVA Inc. Pharmaceuticals 2004 to 2008

Compiled all APR (Annual Product Review) data submitted by required departments, to compose Executive Summary report, Quality Control summary, Production History summary, and Production Yields summary Reports for a product line of 60 products. Created controlled process flow for issuance and distribution of SOPs. Developed databases for SOPs, Change Control, Methods, and Specifications for tracking and trending purposes. Created comprehensive metrics for all Documentation department processes. Performed internal audits of company wide controlled documents. Developed a controlled system for all cGMP official forms/documents. Conducted technical writing activities of all department SOPs and review of company-wide SOPs.

QA Technician/QA Specialist II, Alpharma Pharmaceuticals 2000 to 2004

Supported cross department project management with regard to facility equipment qualifications. Performed internal audits. Oversaw review/approval of all facility equipment qualification protocols, IQ, OQ, and PQ. Assisted in protocol technical drafting. Performed all vendor/contractor cGMP training. Developed strong knowledge of cCGMP. Performed all QA In-process inspection responsibilities and functions related to QA Manufacturing, Cleaning Validation, and Packaging processes. Performed batch record review/audit.

QA Supervisor/Coordinator, DFG/Tyson Foods 1997 to 2000

Led the coordination and implementation of all HACCP (Hazard Analysis And Critical Control Points) processes and documentation within the manufacturing process. Trained all QA technicians and manufacturing operators in HACCP processes. Oversaw all manufacturing operations and supervised 10 direct reports. Directed release and/or quarantine of finished product and raw materials.

EDUCATION

General Business Administration/Accounting, Community College of Vermont

ACCREDITATION / COMPUTER EXPERTISE

CQA, Certified Quality Auditor, American Society of Quality

Kepner Tregoe Certification in Problem Solving and Decision Making

OSHA Certified in General Industry Safety & Health

Certified in Plant Sanitation, AIB Food Safety & Hygiene

Certified in HACCP (Hazard Analysis and Critical Control Points)

Certified in CTFS (Commitment to Food Safety)

Certified in GMP (Good Manufacturing Practice)

Access ~ Fox Pro ~ Office ~ Excel ~ Documentum ~ Lotus Notes ~ SAP ~ GXPharma ~ TrackWise ~ QMAS

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