Manufacturing/Quality Control Associate Resume Framingham, Massachusetts - Hire IT People

CAREER PROFILE:

Detail - oriented, highly motivated, experienced candidate with a strong analytical chemistry background looking for a Quality Control/Quality Assurance Associate, Research Assistant, Quality Control Analyst or similar position on a project team.
The candidate has experience with analytical instrumentation including chromatography (HPLC), UV-Vis, FTIR, MS, ELISA as well as viscometer and moisture analyzer for qualitative and quantitative analysis of carbohydrate products and proteins.
Possess solid documentation skills and familiarity with GMP/GLP.
Candidate has a BS degree in Chemistry plus 7 years experience in the biochemistry field.
An enthusiastic, energetic individual with a strong work ethic and excellent attendance record who works well independently or as part of a team.

TECHNICAL SKILLS:

Skills: Microsoft Office including Word and Excel

EMPLOYMENT:

Confidential, Framingham, Massachusetts

Manufacturing/Quality Control Associate

Responsibilities:

Operate complex systems and equipment in strict accordance with current
GMP's, SOP's, and safety guidelines.
Initial job responsibilities include CIP of process equipment and purification/operation of Microfiltration and
Chromatography systems.
Assist and/or lead the implementation of production procedures and equipment guidelines.
Perform In-Process sample testing, Stability testing, Raw materials inspection, sampling, and testing, Revise SOPs, review documentations.
Maintain cGMP of the lab and follow the actions and rules of all compliance programs (i.e. log book entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment, QC daily laboratory maintenance log, etc.
Managed laboratory purchasing, maintenance of equipment, and inventory.
Knowledge of biological assays including, cell/tissue cultures, SDS-PAGE, western blot, ELISA and bioburdens. Created labels using LIMS System.

Confidential, Franklin, Massachusetts

Quality Control/Column Packing Technician

Responsibilities:

Responsible for making different kinds of columns according to GMP and exceeded daily goals by 50% on average.
Possess an understanding of process theory, equipment operation and working knowledge of manufacturing process following SOP’s.
Tested columns on Agilent HPLC and performed troubleshooting of equipment as needed.
Prepared test samples and buffers and ordered supplies.
Maintain cGMP of the lab (QC Chemistry and Raw Materials Lab) and follow the actions and rules of all compliance programs (i.e. log book entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment, QC daily laboratory maintenance log, etc.
Managed laboratory purchasing, maintenance of equipment, and inventory.

Confidential, Cambridge, Massachusetts

Quality Control/Senior Scientific Associate

Responsibilities:

Responsible for peer reviewing and quality control checking data and documents generated within Formulation Department and entering results into the database.
Collected, processed and maintained excipient Certificates of Analysis.
Prepared organic solvent samples of active pharmaceutical ingredients using Agilent HPLC.
Weighed out solid compounds using balance for thermo gravimetric analysis and differential scanning calorimetric analysis.
Tested solid compounds using X-ray, nuclear magnetic resonance, microscope and hot plate.
Set up experiments using computer and analyzed results.

Confidential, Worcester, Massachusetts

Manufacturing /Quality Control Technician

Responsibilities:

Responsible for analytical testing, labeling and inspection of incoming and utgoing products; managed the approval and release of manufactured materials; established, operated and maintained the Quality Control area and equipment.
Gained proficiency in the following techniques: HPLC, ELISA, UV and microbiological tests. Wrote SOPs and followed GMPs for making saponin extract and analytical tests on animal bleeds.

Confidential, Needham, Massachusetts

Research Associate

Responsibilities:

Responsible for routine laboratory work including analytical chemistry, rheology, Karl Fisher titration and compounding according to SOPs and GMPs.
Conscientious, hard working and detail-oriented employee known for producing quality work with consistent results.
Gained experience using UV, FTIR and Waters Millenium HPLC.

Confidential, Westborough, Massachusetts

Inorganic Chemist

Responsibilities:

Responsible for instrument calibration and conducting inorganic analysis on soil, water and wastewater samples including TOC, pH and solids analysis according to SOPs and GMPs.
Water testings (conductivity, Heavy metals, nitrates), solution and reagent preparation under hood.
Operated computerized test equipment and utilized electronic schematics to troubleshoot, ensuring compliance with specifications and verifying product integrity.