Rebecca Connors

**** *. ******* **.

Bloomington, IN 47404

812-***-****

acumja@r.postjobfree.com

OBJECTIVE Quality Manager, with significant leadership experience seeking challenging career in quality management.

PROFESSIONAL Cook Pharmica Bloomington, IN

EXPERIENCE Quality Control Chemistry Manager

06/11 – 04/16 QC Manager in a cGMP, GLP compliant laboratory atmosphere supporting drug substance and drug product production. Responsible for, and manage, four QC departments.

Duties include:

Validation, qualification, and transfer of analytical methods into the QC department utilizing a phase appropriate approach

Oversee stability program, including onboarding of new programs, in accordance with ICH requirements

Responsible for release of raw material, production support, finished product, and stability samples

Author and review laboratory investigation reports, deviations, and technical documents

Perform forecasting for resource and stability needs

Propose and oversee implementation and validation of new equipment

Interface with investigators during client audits and regulatory inspections

Provide pricing estimates for established and potential clients

Perform trending of analytical method performance and results

Oversee and execute continuous improvement

Represent all QC functions (Incoming, Microbiology, Chemistry) as the department representative in client project meetings

Support QC Metrology and LIMS activities

Acquired extensive knowledge with the following instruments and test methods:

HPLC systems pH and Density meters

UV spectrometry Oxygen Headspace analyzers

FTIR spectrometry Osmometers

Turbidity meters Viscometers

Endotoxin analysis Particulate matter analysis

Karl Fischer Coulometer US Pharmacopoeia

British Pharmacopoeia European Pharmacopoeia

Japanese Pharmacopoeia Polarimetry

Slot Blot Analysis SDS Page

Atomic absorption ELISA

qPCR ICP-MS

07/02 – 06/11 Baxter Biopharma Solutions Bloomington, IN

Quality Control Laboratory Supervisor

Supervisor in a cGMP, GLP compliant pharmaceutical laboratory serving over 150 active clients. Responsible for releasing raw material, in-process, finished product and stability drug substance to ensure purity and compliance with FDA requirements. Responsible for, and supervised the work of twelve Quality Analysts in the laboratory.

Duties included:

Review of laboratory documentation for accuracy and completeness

Create, review, and revise SOPs

Final review and sign-off of Certificates of Analysis and Summaries of Analysis

Perform all Human Resource activities (locating employees, interviewing, hiring, terminations, employee performance review, performance management, promotions)

Conduct laboratory investigations, write Laboratory Investigation Reports and Exception Reports

Daily assignment of testing

Lead laboratory audits for clients as well as regulatory agencies

Train employees on test methods and instrument use

Trouble-shoot laboratory testing problems

Oversee testing including HPLC, biological assays, analytical instrumentation, and Pharmacopoeial wet chemistry techniques

05/01 – 07/02 Heritage Environmental Services Indianapolis, IN

Laboratory Analyst

Prepared samples according to analytes requested, sample matrix, and client need for analysis on the GC/ECD. Performed involved, multi-variable calculations to determine percent recoveries, response factors, and standard deviations while assessing, interpreting, and applying results. Integrated and evaluated chromatograms of unknown substances, including PCBs, pesticides, herbicides, and EDBs, to determine content, potency, and purity.

EDUCATION Indiana University, College of Arts and Sciences, Bloomington, IN

Bachelor of Science, Major in Biology, Minor in Psychology, May 2001.

SOFTWARE Word, Excel, PowerPoint, Lotus Notes, Access, Pilgrim, Qumas

EXPERIENCE eDocumentation Management, Outlook, OpenLab, Chromeleon, Gen5, NWA, OMNIC, TotalChrom, SQL*LIMS, Cambrex WinKQCL, PharmSpec, TrackWise, J.D. Edwards, Registrar, JMP, MiniTab

REFERENCES References will be furnished upon request

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