Specialist, Quality Assurance

Employer
Merck
Location
Wilson, NC, US
Posted
April 17 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007269

Our Manufacturing division in Kenilworth, N.J., U.S.A. is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Manufacturing division has codified its legacy for over a century. Our Manufacturing division’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our Manufacturing division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 
Our Manufacturing division is currently seeking candidates for the position of Specialist, Quality Assurance within the IPT QA Team at its Wilson, North Carolina facility. The Wilson facility, located at the intersection of I-95 and US 264 Alternate, is a 500,000 square foot facility on 225 acres. As a Packaging Center of Excellence for our Manufacturing division, the facility packages a variety of finished goods types for both domestic and international supply including secondary packaging of vial, syringe, sachet, and inhaler configurations. The Wilson facility also includes one of our Manufacturing division's Global Stability Centers of Excellence, which completes stability testing for active pharmaceutical ingredients and finished goods which are manufactured and supplied around the world. The facility has been in operation since 1983, and is located in Wilson, NC. 
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the completion of batch record reviews for domestic, intermediate and finished product releases for domestic markets, defect resolution in packaging operations and control of material throughout the plant, plant investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, and other Quality Assurance related functions as required. The Specialist, Quality Assurance is the primary source of advice, guidance and input regarding quality issues for production personnel and our Manufacturing division and inter-site customers.
The Specialist must demonstrate strong leadership capability and work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands. This position is knowledgeable in domestic regulatory requirements, and ensures site compliance with all expectations. 
Specific areas of responsibility include, but are not limited to the following:
  • Batch record review and intermediate/finished product release activities for domestic distribution.
  • Defect resolution, including use of statistical methods, and control of material throughout the plant site.
  • Plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition.
  • Completion of documentation of plant investigations. 
  • Participation in internal/external GMP audits and regulatory inspections (domestic and international). 
  • Policy/procedure development, interpretation, and implementation. 
  • Review and approval of GMP-related SOPs. 
Completion of job responsibilities in accordance with company policy, applicable government regulations and local procedures in a timely and reliable manner to meet production demands.

Qualifications

Education Minimum Requirement: No minimum requirement.
Required Experience and Skills**: A minimum of 3 years experience in a GMP pharmaceutical manufacturing facility either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc..
Preferred Experience and Skills: Batch release experience and  strong knowledge of domestic regulatory requirements.

Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: none
Company Trade Name: Merck

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