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Quality Lab Manager

Location:
United States
Posted:
August 28, 2012

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Resume:

Carin L. Hallock

****Sylvanie St.

St. Joseph, MO 64501

Cell 208-***-**** Email: lxiukw@r.postjobfree.com

Education: B.S. in Chemistry, emphasis Biochemistry - Pacific Union College 1991

Certifications:

• Management Training 1995 - Molecular Biosystems

• Hazard Analysis and Critical Control Points (FDA) 2010

Publication: Deletion of the Trichodiene Synthase Gene of Fusarium venenatum: Development of two Systems for Repeated Gene Deletions. Fungal Genetics and Biology, V28, N1, p 68-78. 1999.

Experience: Blue Sun, St. Joe Refining, St. Joseph, MO 303-***-**** www.gobluesun.com

Quality Laboratory Manager, 2011 – current

Accomplishments: Prepare the lab for audit readiness by contractual and regulatory authorities. Validate all AOCS and ASTM methods required for raw material verification and final product release. Review Contract lab data for correctness and completeness. Set-up a new lab for production support and determine dosing verification to assist production.Write verification or validation protocols and SOP’s based on final validation reports. I manage multiple product timelines and status for production, determine when load out capacities have been met while C of A’s are generated and tanks are sealed until release.

Teva Animal Health, St. Joseph, MO 816-***-**** www.tevanimalhealth.com

Scientist, Analytical Services-QC, 2011

Accomplishments: Validate Residual solvents methods (GC) for API’s and raw material verification per VICH and USP guidelines. Review Contract lab data for correctness and completeness. Design and implement new lab procedures to provide optimized analytical methods. Write verification or validation protocols and SOP’s based on final validation reports. Manage multiple product timelines, status for production and ensuring release testing is complete.

Aptuit Kansas City, LLC. Kansas City MO 816-***-**** www.aptuit.com

Scientist, QC- API 2010-2011

Accomplishments: Developed Residual solvents methods (GC) in support of multiple projects. Validated and reported developed methods. Provided Purity data based on optimized (HPLC) methods and supported client projects on a timely bases. Kept the Project Managers updated on status and immediate project focus for the analytical QC data deliverables.

Clearsprings Foods, LLC. P.O. Box 712 Buhl, ID www.clearsprings.com

QA Team Lead, Specialty Plant 2009-2010

Accomplishments: Created New Product Specifications in support of marketing and production

campaigns. Lead the QA team in a HACCP compliant environment. Tracked QA data for specification monitoring, including ‘out of spec’ results for temperature, weight, etc. Maintained QA coverage of two shifts, including regularly scheduled ‘overnight campaigns’ with 12 hr. coverage.

Kiff Analytical, LLC, Davis, CA 530-***-**** www.kiffanalytical.com

Quality Assurance Consultant – 2005-2010

QA Analyst/Technical Document Specialist 2006

Accomplishments: As a member of the Management Training Taskforce, I structured and implemented a Document Control system for Technical Training Materials, Training Modules (TM’s) and SOP’s. Priority of document development was focused on Technicians. Preparation of samples, calibration curves, and QC spiking following regulated methods. The Training Modules (TM’s) that were written involved the identification and process mapping of lab tasks. The Training System/Process Mapping moved the comprehension and technical ability and skills of Technicians from a 2 yr. period into a 6 month timeframe. A highly efficient and productive training system was implemented as a result of my documentation and process mapping.

QA Responsible for bringing up a new analytical lab by guiding studies for Initial Demonstration of Capabilities as required by ELAP and NELAC auditors. I directed the data studies, prepared and wrote the validation packages that was submitted to CA ELAP. All new methods and analytes were approved. In addition to writing the Training Modules for the new lab, I continued to write Training Modules for the Analytical Chemists Training program. Assisted with all QA activities; procedure audits, calibration curve review, Corrective Actions database monitoring, QA investigations, etc. Most recently worked with various instrumentation salespersons for demonstrations of various new analytical instruments and provided technical guidance for Kiff’s management in support of another new lab. Following purchasing, I directed the validation studies for the additional new lab methods, as well as wrote all the validation studies and documented the Executive Summaries. Audit was completed in Nov. 2009 with certification approval for all new analytes/methods in January 2010.

Novozymes Biotech, Davis, CA 530-***-****

www.novozymes.com

Protein Chemist-Senior Research Associate 1999-2003

Protein Chemist-Research Associate 1996 -1999

Accomplishments: Developed and implemented assays for enzymes, proteins and analytes of interest in support of prokaryotic and eukaryotic molecular biologists. Purified and characterized (pH/temp. optimum, ran gel (SDS) electrophoresis, and froze/lyophilized) novel proteins/enzymes and developed studies to support patent applications. Documented experimental assay results, analyzed runs and concentrations for optimum detection linearity, determined precision and accuracy. Wrote SOP’s based on documented assay development work, crosschecked with outside labs and implemented assays. Provided all project groups with reliable data in a timely manner and assisted in determining trends that identified top transformants, strains or feed/temp/pH conditions.

Participated in all project meetings for in-house R&D work as well as provided analytical support for projects that had moved to pilot and production scale fermentations. Transferred purified, characterized protein samples as well as analytical methods and information to QC labs in Denmark.

Molecular Biosystems, San Diego, CA 858-***-****, 858-***-****

QC Associate ll 1994 -1996

Responsibilities: Implementing and validating the QC analytical procedures and training of all QC personnel on the newly validated assays in support of this FDA fast track Clinical Trial project. Documented results as well as any out of control situations and the corrective actions taken. Analyzed in-process Clinical Trial lots for a new Human Serum Albumin pharmaceutical.

Cholestech Corporation, Hayward, CA 510-***-**** www.cholestech.com

QA Chemist ll 1993 -1994

Weston Analytics, Stockton, CA –sold to Recra www.westonsolutions.com

St. Joseph’s Medical Center, Stockton, CA 209-***-****

Senior Lab Assistant 1990 -1991

San Joaquin County Hospital, French Camp, CA 209-***-****



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