Quality Assurance Auditor (FullTime)

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Helps ensure that Eyetech products are consistently manufactured according to predetermined quality attributes, cGMPs plus US and overseas regulatory requirements by performing quality audits, communicating findings and observations in written reports and conducting follow-up. Performs audits of Eyetech’s quality systems to ensure that they are being followed, documented and maintained according to company policies and procedures. Audits GMP laboratory operations performed by Eyetech and its contractors to help ensure that raw materials, containers, closures, in-process and final products are appropriately sampled and tested following company procedures and test methods. Audits primary and secondary suppliers of Eyetech including raw materials, packaging components and labeling as well as contract manufacturers and packagers for compliance to cGMPs and company requirements. Performs mock audits of facilities in preparation for pre approval inspections. Ensures that written responses to audit reports are received, and that these responses contain appropriate corrective actions and timelines as necessary to address noted findings and observations. Enters all audit findings, observations and resultant corrective actions and timelines into the company compliance tracking database, and uses the database and other means to ensure that all corrective actions are implemented and confirmed for adequacy. Provides both immediate notification of critical compliance findings and routine periodic written updates of audit and compliance tracking activities to Eyetech senior management.

Qualifications

• A minimum of 3-5 years experience in the pharmaceutical or allied industry is required, with experience in Quality Assurance, Quality Control, Validation or Regulatory Affairs.
• A B.S. degree in a technical field such as chemistry, biology or pharmacy.
• Strong working knowledge of cGMPs. Past experience with FDA or overseas regulatory authorities a plus.
• Past experience in performing quality audits is required. Must be an ASQ Certified Quality Auditor or attempt certification within the first year of employment.
• Strong written and verbal communication skills. Must be able to deal effectively with employees at all levels.