US-PA-Newtown: Sr. QA Associate in biotech

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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.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/