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| Jim... |
 Posted: Tue Oct 27, 2009 11:41 am |
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US-PA-Newtown: Sr. QA Associate in biotech
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99892982_Sr__QA_Associate_in_biotech.html
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/
Date: 27-Oct-2009
Sr. QA Associate in biotech
Participating in customer audits by:
* Working directly with the Director, Corporate Regulatory & QA/QC
Services in hosting client audits. * Working directly with the
Director, Corporate Regulatory & QA/QC Services in responding to
client audit observations. * Being responsible for maintaining the QA
files for customer audits.
Designing, developing, implementing, leading and managing all internal
audit programs by
* Managing internal audits as requested by B-I senior management or
the Director, Corporate Regulatory & QA/QC Services * Auditing systems
and staff competency for overall facility compliance to FDA
requirements * Participating in the development and maintenance of all
quality systems and process improvements
* Leading and investigating quality issues and implementing corrective
actions; identifying departmental strengths and weaknesses *
Developing and implementing proper document management and change
control processes * Providing regulatory guidance to management team
Facilitating the identification and development of Standard Operating
Procedures (“SOP”) by:
* Assist with the writing, revising, reviewing and approving of all
SOPs * Providing training and guidance to staff regarding compliance
and interpretation of SOPs
Verifying corporate compliance with regulatory requirements and
industry standards by:
* Ensuring internal standards (Policies, SOPs, et al) are in
conformity with applicable regulatory agency’s regulations and
guidance. * Ensuring, through conducting internal audits, internal
standards and staff performance are in compliance with applicable
regulatory agency’s regulations and guidance * Conducting internal
audits of company policies and procedures * Conducting audits of any
vendors utilized to conduct business. * Creating and revising SOPs and
documents as necessary. * Identifying compliance gaps and providing
support and suggestions for remediation. * Maintaining an internal
CAPA (Corrective Action/Preventative Action) database for internal and
vendor audits. * Coordinating corporate document and media management
and archival efforts.
QUALIFICATIONS:
Qualified candidates must have a Bachelor’s degree, preferably in the
life sciences.
Additionally candidates must have 3+ years current experience in a
Regulatory or Quality Assurance role within the pharmaceutical
industry, familiarity with US and EU regulations and guidance, and
proven ability to work with and direct teams to accomplish goals.
Demonstrated above average written communication skills in the English
language is required.
3+ years management experience in clinical development within the
pharmaceutical industry, and prior experience in creating and
maintaining SOPs is preferred.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/ |
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