Director of Quality - (US-ID-Sandpoint - 83864)

Compensation: $115K - $115K / Year
Minimum Education: Bachelors
Job Type: Full Time
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ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for all regulatory compliance programs for the company.
Direct the internal audit process, including the oversight of GMP audits of the production facility on a regularly scheduled basis, and as necessary.
Lead the external audit process, including preparation for ISO 9000 and customer audits.
Primary contact for all external audits.
Conduct management reviews of the company Quality system.
Review customer and regulatory requirements to ensure company compliance and to stay abreast of new or updated regulations.
Member of the Document Review Board.
ISO 9000 management representative.
Primary FDA contact, including completing the annual FDA registration updates and keeping Drug and Device listings current.
Ensure regulatory compliance on all materials and products.
Consult in reviews of NCM's to ensure trends or systemic issues are identified and addressed.
Audit records of finished products for compliance with manufacturing procedures and cGMP's to ensure quality and regulatory compliance.
Analyze audit data and prepare reports for management review and continuous improvement initiatives.
Perform tests of controls to provide an evaluation of the company's internal control system, and prepare audit reports for these tests, documenting exceptions to established policies and procedures.
Perform external quality audits on suppliers to ensure compliance with product specification.
Review all release documents to ensure compliance with Standard Operating Procedures (SOP).
Maintain Quality Assurance and Audit files for facility.

MINIMUM REQUIREMENTS:
Bachelor's Degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
Minimum 10 years experience providing GMP regulatory compliance in Manufacturing or Quality Assurance.
Minimum 3 years experience in an FDA facility.
Prior experience in a Pharmaceutical Manufacturing facility preferred.
Detailed knowledge of cGMP, ISO 9000, and FDA requirements.
Proven experience implementing quality systems in a GMP environment.
Auditing certification preferred.
Prior supervisory experience.
Excellent communication skills, both verbal and written.
Excellent analytical and problem solving skills.
Strong leadership skills.
Proficient with Microsoft Office products, including Word and Excel.
Ability to work both independently and as a member of a team.
Ability to prioritize tasks to meet established timelines.
Excellent attention to detail.
Good interpersonal skills.
Good organizational skills.


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