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| Employer Name: BiotechCrossing |
SpiderID: 2329490 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/1/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Review and approve master batch records, product specifications, analytical procedures and SOPs. * Review and approve executed batch records for API, intermediates and drug product (bulk and finished goods) and issue CoA * Write and revise Quality systems SOPs as necessary to maintain compliance to cGMPs. * Conduct GXP training * Perform/coordinate investigations related to OOS, product complaints, and deviations. * Establish and monitor Quality Assurance programs and procedures to ensure conformance and compliance to Momenta Pharmaceutical's Quality Policies, procedures and regulatory standards. * Perform Quality audits of contract manufacturing sites, test laboratories, and clinical sites to ensure compliance to appropriatefunction. * Assist with audit preparation and any post-audit follow-up. Reports to the Associate Director of Quality Assurance.
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
https://www.employmentcrossing.com/lcsignin.php?refid=1522
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.biotechcrossing.com
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