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Candidate Info
years in workforce
years at this job
Biology
Associate QC Chemist II
Executed release and stability Quality Control tests for both in-process and finished manufactured products, as well as Intermediate Precision for new products. Performed Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectrometry (FTIR), dissolution, disintegration, hardness, and moisture tests; operated, troubleshot, calibrated, and repaired equipment and instrumentation. Provided training to Chemists on new methods, operation of dissolution equipment, and dissolution calibration. Maintained and updated all records and lab books as well as training records; presented results to stakeholders and drafted reports.
- Served as member of lab improvement teams; developed and introduced new test procedures, operating procedures for new instrumentation, and updated existing procedures to improve accuracy and results.
- Effectively organized daily workflow and maintained excellent record of completing 100% of all tests on time throughout six-year tenure, including highly complex and time-consuming procedures.
- Prepared and delivered business case to management to purchase new instrumentation.
- Successfully increased department productivity by adding additional raw material testing and supporting other analysts in their projects.
Candidate Info
years in workforce
years at this job
Chemistry
QC Chemist/r&d
Time allocated between R&D and QC as determined by needs of production. R&D involved lowering VOC, reformulating to incorporate new raw materials, and meeting requirements for specific customer requests.
- Prepared experimental formulas for testing and evaluation per marketing requirements.
- Operated and maintained R&D lab for manufacture of new products on small scale.
- Worked with production to develop procedures in full-size tanks.
- Performed QC testing and wrote "corrections" for production in plant as needed. Organized documentation, retains, drawdowns of all QC work for future storage.
- Integrated new product formulas into production after a former competitor was purchased.
Candidate Info
years in workforce
years at this job
Chemical Engineering
QC Chemist
Tested/Retested incoming and in-process chemical compounds following correct and proper protocols outlined by SOP's and Compendia references.
- Used analytical instruments for measuring specs (Gravimetry, Volumetry, AA, GC, HPLC, FTIR, PH-meter, K.F, UV-VIS, Calibration instruments).
- Demonstrated instrumental and technical competence with operating and maintaining IR, and UV spectroscopy.
- Provided technical expertise in the design and implementation of a quality control program.
- Devised new technical application of industrial chemicals and compounds. Developed new chemical processes.
Candidate Info
years in workforce
year at this job
Bachelor of Arts
Chemistry
Chemistry & Biology
QC Chemist III, (contractor)
Developed and validated GC methods for Drug eluting stents and assisted in HPLC methods.
- Conducted routine and non-routine analysis of raw materials, in progress and finished formulations & special projects on analytical problems on a strict timeline.
- Compiled data for documentation of test procedures and prepared protocols, reports and STM (SOP).
- Reviewed data obtained for compliance to specifications and report abnormalities and training chemist.
- Performed special projects on analytical and instrument problem solving and updating the STM as needed.
Candidate Info
years in workforce
months at this job
Chemistry
QC Chemist I
Experience working in a FDA regulated environment
- Prepared mobile phase and a variety of assays for HPLC testing
- Prepared and ran samples for pH testing
- Experienced in Quality Assurance, such as reviewing completed documents of other chemist and checking for good documentation practices (GDP), meeting specification requirements, and errors.
- Implemented the use of MS excel for documentation of stability testing data, which lead to an increase of efficiency of 50% and eliminated errors made during transcribing
- Initiated improvement to existing processes by replacing manual glass pipettes with automatic pipettes, which leads to more accurate results between operators and reduce lead time for processes involving a pipette
Candidate Info
years in workforce
years at this job
Business Administration
Quality Control Manager/qc Chemist
Created and implemented a process driven internal audit program
- Problem solved using Root Cause Analysis tools for nonconforming materials
- Supervised and provided leadership for five laboratory technicians
- Authored and implemented Quality and Laboratory Standard Operating Procedures
- Produced and initiated a new laboratory training program
- Purchased and implemented new analytical technologies in the Quality Control lab
- Participated in managerial leadership training
Candidate Info
years in workforce
year at this job
Biomedical / Chemical Engineering
QC Chemist
Analyzed routine analytical testing of generic pharmaceutical finished products for release into commerce and stability samples of marketed pharmaceutical products.
- Performed API assay and related substance testing, Content Uniformity, Dissolutions, Blend Uniformity and Cleaning Validation sample testing as per in-house, USP or EP monograph.
- Communicated questionable and out-of-specification results.
- Provided analytical support to process validation group.
- Adhere to company SOPs and practices cGMPs on a daily basis.
- Initiated any planned or unplanned deviation reports.
- Participated in SOP review/revision process.
Candidate Info
years in workforce
years at this job
Biochemistry
QC Chemist
- Conducted analytical tests on samples of Raw Material/Finished products/Cosmetics/ Environmental by HPLC, Dissolution, and other analytical instruments, in accordance with the company and USP specifications
- Communicated all failing or unexpected results to supervisor in a timely manner
- Assisted with request for ordering laboratory supplies
- Documented and reported results as per established SOP
- Investigated new methods under the guidance of senior analyst or supervisor
- Performed preventative maintenance, calibration and troubleshooting of analytical instruments as required
Candidate Info
years in workforce
months at this job
Chemistry
Chemical Engineering
QC Chemist
Analyzed a variety of pharmaceutical generic drugs in assay, related substances, and dissolution testing
- Reviewed, authorized and released other analysts' completed data packets to Quality Assurance group
- Performed Method validation and technical writing
- Conducted method transfers from India lab facility to USA facility
- Troubleshot HPLC, GC, and Karl Fisher instruments
- Served as Team lead on second shift
Candidate Info
years in workforce
years at this job
Biology / Allied Health
QC Chemist
Basic knowledge of analytical instrumentation with strong technical and interpersonal skills
- Strong working knowledge of UV, KF, Dissolution, HPLCs
- Provided analytical testing for materials and production, including but not limited to data analysis and reporting
- Followed cGMPs and SOPs to conduct compliant testing
- Identified suspect data and works with management to complete an investigation
- Maintained proper documentation of laboratory data, complete testing, data evaluation, and LIMS reporting
- Assisted in identification of improvement opportunities for Workgroup and QC
Candidate Info
years in workforce
years at this job
Toxicology
QC Chemist
Routine raw material and finished product testing: kinetic drug release, GPC-SEC, FTIR, HPLC, and GC.
- Equipment support: Instrument maintenance, qualifications, and specification creation.
- Developed and managed stability program and acted as stability team lead.
- Provide support and guidance for external and internal audits.
- Use of SAP to order lab equipment and supplies.
- Coordination with Incoming Quality Assurance to ensure timely release of raw goods to production.
- GMP documentation per 21 CFR 211.
Candidate Info
years in workforce
years at this job
Chemistry
QC Chemist
- Prepped and analyzed raw materials and several in-process/finished products (copolymers) using: GPC, GC, FTIR with UATR, DSC, MFI, autotitration, Durometer hardness (Shore A and Shore D), viscosity, tensile (Instron), and absorption and moisture testing
- Performed instrumental troubleshooting
- Proficient in cGLP and cGMP practices
- Revised and executed SOPs
- Assisted in preparation for company’s ISO certification
- Company transferred from Australia, built lab from bottom up (instrument set up, safety, protocols, IQ/OQ implementation, archived data and retains, various other tasks as necessary)
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