Molly Doan

Castro Valley, CA 945**-***-*** **** ac8lre@r.postjobfree.com

QUALITY CONTROL SUPERVISOR

A Quality Control supervisor with 9 years of experience in managing of finished product, stability and process validation samples in a solid dosage pharmaceutical industry. Proven abilities in managing a team of QC chemists, leading laboratory investigations and working in cross functional groups to ensure rigorous quality to FDA and cGMP standards.

Key Skills include:

●Managing chemists

●Laboratory Investigations (Pathwise)

●CAPAs/Deviations

●cGMP compliance

●QC Quality systems (LIMS, Empower)

●Employee training/development

●Internal audit and FDA inspection

●Laboratory testing

●Trackwise, gLIMS, Veeva and Empower

●Laboratory Optimizator/Continuous improvement

PROFESSIONAL EXPERIENCE

AMNEAL PHARMACEUTICALS, INC. (formerly IMPAX LABORATORIES) 2006-Present

Hayward, CA

Supervisor, QC Product Release (2010-Present)

Supervised the QC Product release group responsible for laboratory testing of finished product, stability, in-process, cleaning verification and product qualification

●Established a weekly testing schedule for all direct reports to ensure the timely release of finished products, stability, clean verification and in-process samples

●Ensured that chemists are adequately trained such as HPLC, GC, KF, Dissolution or UV to perform their tasks following procedures and cGMP/cGLP

●Led and supported laboratory investigations/deviations/CAPAs

●Troubleshot analytical problems

●Revised and reviewed company SOPs and performed change controls related to laboratory methods and specifications such as worksheets and method updates per USP

●Worked collaboratively with Quality Assurance and Regulatory Affairs to ensure timely availability of lots release, stability data and other required analytical data

●Collaborated with QC Laboratory Technical Services (LTS) group in the execution of method validation/verification/transfer protocols.

●Collaborated with LTS in the execution of aberrant peak protocol due to FDA audit

●Collaborated with Technical Services (TS) group in the execution of protocols such as Process Performance Qualification (PPQ) and Demonstration to ensure the submission/qualification batches release on time

●Provided support for internal audits to analytical testing by reviewing the test methods

●Supported in FDA inspections and coordinated responding to FDA requests and questions

●Supported to completed Quality Improvement Projects to remove blend uniformity testing for fives products.

●Supported laboratory harmonization between QC and R&D by standardized the laboratory such as combined the SOPs and improved the lab efficiency

●Participated in the BMS project to improve laboratory efficiency

Team Lead, QC Product Release (2009-2010)

Managed the in-process team by scheduling, training and supervising 5 chemists.

●Established testing schedule for analysts

●Conducted laboratory investigations/deviations/CAPA

●Reviewed notebooks for compliance

●Troubleshot analytical problems

●Supported FDA inspections

Chemist II, QC Product Release (2008-2009)

Chemist I, QC Product Release (2006-2008)

●Performed Assay, Blend Uniformity, Content Uniformity and Impurity testing by HPLC and ID testing by FTIR and UV

●Conducted Karl Fischer titration testing

●Conducted Loss on Drying and Hardness testing

●Managed the laboratory’s standard inventory and by ensuring standard availability and purchasing standards as needed.

EDUCATION

Bachelor of Science, Cal State East Bay, Hayward, CA

TECHNICAL SKILL

Word, Excel, Outlook, Trackwise, Empower, Veeva, PowerPoint, Chemstation, Tiamo

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