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Job Title: QA Manager
Category:  Scientific (1210)
Description:  Managing the Quality Assurance function across all shifts in support of the production operations. Position requires management of quality assurance supervisors, inspectors, auditors and complaint coordinators.

(25%) Investigate, troubleshoot, resolve and document as required all quality issues that arise. Work with Operations staff to assure compliance. Participate in the CAPA process as needed.

(25%) Initiate, review or complete documentation as required. Documentation includes but is not limited to the following: Batch Records, MPIs, SOPs, Work Instructions, Quarantines, Investigations, Deviations, Protocols, Complaints, Training Records.

(10%) Develop and drive improvements in quality systems, business systems and processes.

(10%) Develop assigned staff to increase teamwork, individual capability and organizational flexibility.

(5%) Participate in performance and closeout of customer audits. Provide support for regulatory audits.

Responsible for managing the Quality Assurance function in support of the production operations. Responsibility is for activities on 1st, 2nd and 3rd shift. Position requires management of quality assurance supervisors, inspectors, auditors and complaint coordinators in the daily support of production operations, resolution of quality issues, troubleshooting, and documentation. Additional responsibilities include driving improvement in QA systems & processes and team/ staff development.
Requirements:  Knowledge/Skills Requirements:
Knowledge and experience in cGMP / FDA regulations. Experience in regulatory audits desired.
Excellent verbal, written and interpersonal communication skills
Demonstrated ability to manage and lead personnel
Demonstrated ability to handle multiple complex task and make timely appropriate decisions with respect to product quality, compliance and customer complaints
Strong math (statistical), troubleshooting and computer / software skills


Education
Bachelor Science degree in Engineering or Science


Experience
8+ years to include a minimum of 3 years of supervisory experience
Location  Not specified
Minimum Experience (yrs): 
Required Education:  Not Specified


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