Quality Assurance Manager (GMP) - Essex County, NJ | Biospace
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Quality Assurance Manager (GMP)

Omega Management Group

Location:
Essex County, NJ
Posted Date:
8/29/2017
Position Type:
Full time
Job Code:
4813
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

JOB TITLE:      Quality Assurance Manager
DEPARTMENT:   Quality Assurance
REPORTING TO:   Director of QA

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
•   Supervise team of QA Compliance Specialists and a CAPA Coordinator
•   Responsible for the daily oversight of the Investigation Process and CAPA Systems
•   Ensure that quality events are thoroughly investigated, driving to true root cause and the identification and implementation of effective CAPA solutions.
•   Provide QA support for the review of controlled GMP Documentation and ensure that team of  QA Compliance Specialists perform thorough and timely reviews
•   Manage and maintain the Internal GMP Audit program that assures compliance and drives continuous improvement of processes, process compliance, and product quality. Ensure timely execution of facility audits and provide the feedback needed to ensure readiness.
•   Provide leadership to continuously drive improvement to the assigned elements of the quality system required to support Current GMPs and manufacturing processes.
•   Develop predictive metrics and KPIs from the Internal Audit, Investigation and CAPA Systems
•   Represent the quality assurance department on internal and external cross functional project teams.
•   Management Competencies: develops and maintains an organization of high performing individuals

Requirements

QUALIFICATIONS/REQUIREMENTS:  
•   BA or BS degree in a scientific discipline.
•   At least 5 years of experience in cGMPs at an operational level supporting manufacturing or testing in a pharmaceutical environment with an additional minimum of 5 years of experience in a direct QA function working within / responsible for Quality Systems
•   At least 3 years of experience directly supervising direct reports