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Manager - QA - Critical Systems and Validation

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POST DATE 9/6/2016
END DATE 12/19/2016

Career Connection Network Buffalo, NY

Buffalo, NY
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


Our Global client is looking to hire as the former incumbent of this position has taken on a new role within the organization. The position will pay between $80-$110K + bonus eligibility. Our client will offer a relocation package, as appropriate. This position is located in a suburban location just outside of Buffalo, NY. MUST HAVE PHARMACEUTICAL MANUFACTURING EXPERIENCE!


* Owner of the facilities and equipment qualitysystem (FUME). Responsible for developing, evaluating, and ownership of all quality characteristics of the plant facilities and equipment qualitysystem (FUME QualitySystem).
* Manage a team of QualityEngineers.
* Provides quality oversight for software validation, equipment qualification, and facility commissioning and qualification, and validation. Reviews and approves protocols/validations/qualifications.
* Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc.). Analyzes data and implements both corrective and preventative actions to enhance processes.
* Executes Gap Analysis and/or Risk Assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
* Provides QA review and approval of deviations and validation protocols/reports. Ensures completeness, accuracy and compliance of all documentation. CAPA management of critical systems, metrology, and validation areas.
* Interacts with the regulatory officials to convey the compliance level of the facilities and equipment qualitysystem during regulatory inspections.
* Leads, manages or participates in quality projects and teams to implement improvements to the facilities and equipment qualitysystem infrastructure to meet regulatory requirements.
* Independently and proactively seek new information to:
* Assure current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, ISPE, etc.
* Share with site QA and all other applicable departments.
* Provides training to appropriate personnel related to facilities and equipment qualitysystem.
* Trends and tracks critical system data as appropriate.


* Must have B.S. DegreeEngineering, technical science degree or Associates Degree with relevant experience. CQE or Black Belt certification a plus.
* Minimum 5 years _QA/QC _experience in pharmaceutical or other highly regulated industry.
* Working knowledge of cGMP practices. Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.
* Must have experience in qualification and validation practices.