Quality Scientist

Massachusetts  ‐ Onsite
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Keywords

Description

Responsibilities
Develop and qualify analytical methods for release, in process testing, and product characterization to support ITP product.
Establish and maintain positive and collaborative relationship with other quality groups.
Will be responsible for implementing new technologies, transfer assays to other quality groups and continue to support assays by trouble-shooting.
Plan, coordinate and execute the method development and validation activities associated with product.
Prepare technical/qualification/validation reports for supporting analytical method for optimization, troubleshooting and testing.
Examine test results, documentation and trending data to identify potential areas of improvement.
Respond to discrepancy reports, investigations, and experience required aberrant results.
Work closely with Quality Science and Technology, Quality Control Analytical and process groups to ensure that test methods plans are developed, executed and approved in a timely fashion to support the ITP process validation.
Write and/or review analytical method SOPs, as required.
Maintain awareness in technical advancements within the biopharmaceutical industry, with emphasis on analytical method validation, characterization of biological molecules and preparation of critical reagents required for test methods.
Interact with teams responsible for the evaluation, improvement and qualification of new equipment and instrumentation.

SKILLS:

Requirements
BS degree in Biochemistry or related fields with two plus years or one plus years (with MS) of biotechnology/biopharmaceutical experience.
Experienced in development and validation of test methods and equipment as well as electronic laboratory and data management systems.
Possess demonstrated skills in communication, organization, and teamwork.
Working knowledge of US Pharmacopoeia, FDA and ICH guidelines/regulations and regulatory trends/reforms relating to quality control practices is required.
Experience with introduction of new technologies into the regulated testing environment is preferred.
Experience in analytical techniques such as HPLC, ELISA, peptide mapping, carbohydrate analysis, CE, SEC, and basic statistical analysis of the data is preferred.
Analytical Techniques, 1-3 years
Good Manufacturing Practices (GMP), 1-3 years experience required
Quality Control, 1-3 years experience required

Start date
n.a
From
Synectics
Published at
30.04.2014
Project ID:
701182
Contract type
Freelance
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