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Quality Control Analyst

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Location
Lexington, MA

Profile

Job Title:

Quality Control Analyst

Position Description

Conducts routine and non-routine analysis of raw materials, stability samples and in-process and finished formulations according to standard operating procedures.

Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains laboratory equipment.

Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities.

Revises and updates standard operating procedures as needed.

May perform special projects on analytical and instrument problem solving

Position Responsibilities

Analytical testing of in process, development, stability, raw materials and final product samples.

Performance of testing in accordance with standard operation procedures.

Perform job function in accordance with the Antigenics Quality Policy and Manual as appropriate.

Testing included but not limited to HPLC, SDS-PAGE, Western Blot, Bradford and ELISA methods.

Support the execution of approved protocols for the validation of analytical instruments and test methods.

Revision and development of standard operating procedure as needed.

General laboratory support, including but not limited to sample receipt, inventory control, reagent preparation and equipment and instrument maintenance.

Monitoring of temperature controlled units using REES monitoring system.

Peer training and data review

Individual must be flexible, work well in a team environment and possess developed organizational skills.

Prior knowledge of cGMPs.

Position Requirements

Requires B.S. in a scientific discipline or equivalent

Minimum 0-3 years experience in a GMP environment

Equivalent is a minimum of 10 years plus relevant experience in a GMP environment.

Senior requires BS/MS or equivalent with 3-7 years relevant work experience.

HPLC experience and GMP

Benefits

Medical, Dental, and Vision Insurance

401K Plan with Company Match

Flexible Spending Account

Life and AD&D Insurance

Relocation Assistance

Job Requirements

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Company info

Randstad Pharma
Website : http://pharma.randstadusa.com/

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