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发帖数: 95 | 1 【 以下文字转载自 WashingtonDC 讨论区 】
发信人: hydration (hydration), 信区: WashingtonDC
标 题: Quality Assurance Position, BioPharma company in Gaithersburg
关键字: Quality Assurance Specialist,QA
发信站: BBS 未名空间站 (Mon Jan 16 15:47:36 2012, 美东)
We are a Biotech/Pharmaceutic company develop novel vaccines for
inflammatory diseases including rabies, influenza, rotavirus, measles,
Japanese encephalitis, et al. Currently, we are looking for a qualified
individual to fill the position of: Quality Assurance Specialist
RESPONSIBILITIES:
1.To supports the evaluation and disposition of labeling, raw materials,
intermediates and finished products through timely compliance evaluation of
batch records, laboratory results and other cGMP documents.
2.Implements quality policies, manages quality systems and assists in
facilitating regulatory compliance inspections.
3.Review of documents for completion, accuracy and compliance with policies
and procedures. Maintain all controlled procedures and forms required for
GLP/GMP activities.
4.Review and understand laboratory records and test data to assess
compliance with protocol requirements, laboratory procedures and applicable
industry practices.
5.Observe technical and professional staff for adherence to laboratory
health and safety, SOP and GLP standards.
6.Maintain properly indexed quality assurance records, including inspection/
audit status reports, studies inspected, and phase of study inspected.
7.Participate in validation activities for equipment and software, SOPs.
8.Develop expertise in vaccine cGMP regulations and ISO 9001 standards to
provide guidance, training and compliance assessments as needed.
REQUIREMENTS:
1.B.S. / B.A. degree in Biology (or related field) or a minimum of 3 years
or more of relevant experience in Pharmaceutical Production, Testing or
Quality Assurance.
2.Thorough knowledge of cGMPs associated with the production of bulk
pharmaceutical products.
Please send message to me requesting how to apply. |
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