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Senior Specialist Quality Systems & Compliance

Merck


Location:
Durham-RTP, NC
Date:
06/22/2017
2017-06-222017-07-22
Job Code:
QUA005988
Merck
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Job Details

Job Title: Senior Specialist Quality Systems & Compliance  - QUA005988

Description
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
 

Quality Systems and Compliance – Deviation Management and Corrective Action / Preventive Action (CAPAs)

 

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products.   Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

 

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Overview / Basic Functions & Responsibilities:   

 

The Sr. Specialist position in Quality Compliance is responsible / accountable for Deviation Management, CAPA management, Product Quality Complaints (PQC), and Adverse Event (AE) investigation activities that support the Durham Vaccine Manufacturing Facility.  The incumbent serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management, CAPA management, Product Quality Complaint investigations, Adverse Event investigations, and metric generation.  Quality System or GMP Walk-Through Audits, Annual Product Review support, Change Control support, SOP approval, Permanent Inspection Readiness projects, and direct regulatory inspection support are additional areas of focus.

 

The incumbent will provide hands-on assistance in the development, implementation, and monitoring of Deviation Management and CAPA management.  Additionally, the incumbent will be responsible for conducting and supporting customer Product Quality Complaint investigations, Adverse Event investigation, and Quality systems metric generation.  By providing administrative support, the successful candidate will assist the Director and Associate Director with building and/or improvement of programs by defining requirements established via in depth review of existing Deviation/CAPA Management and Complaint/Adverse Event Quality Systems, which will be done in concert with strategic direction facilitated by our global business model and regulatory compliance.   The incumbent will also be responsible for development of metrics, ensuring consistency across the site, and presenting systems during audits and inspections.

 

Primary Roles include, but are not limited to:

 

• Quality review and approval of Deviations and CAPAs associated with Vaccine Manufacturing Facility and presenting investigations during regulatory inspections

• Assist management in the tracking and monitoring of the Deviation/CAPA and Complaint/Adverse Event Management Systems. Perform quality checks to ensure accuracy, completeness and proper usage of data. Prepare and/or review activity, progress, and performance metrics reports

• Assist in the reporting and assessment of critical data by indexing, archival, and retrieval of Deviation/CAPA and Complaint/Adverse Event System data

• Participates in and/or leads Lean Six Sigma process improvement projects

• Responsible for development, implementation, and management of CAPA effectiveness program

• Responsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous improvement

• Serves as Subject Matter Expert (SME) for areas of responsibility

• Perform SOP development and review / Quality approval

• Direct support of regulatory inspections and audits; defends Quality Systems, Deviations, CAPAs, Complaints, and Adverse Events during regulatory inspections

• Provide daily maintenance, review and oversight of Deviation Management/CAPA and Complaint/Adverse Event System data throughout the document lifecycle

• Perform data analysis and metrics to ensure quality of the Deviation/CAPA & Complaint/Adverse Event Management System programs

• Assist in evaluating existing Deviation, CAPA and Complaint/Adverse Event systems on the global and local level and assist in the implementation of consistent management process across the site

• Perform Quality System Audits or GMP walk through audits

• Change Control approval

• Assist in Permanent Inspection Readiness (PIR) projects

• Support Annual Product Reviews

• Support of Biological Product Deviation Report ( BPDR) submissions to FDA associated with PQC, AE, or site Significant Deviations

• Investigation of Product Quality Complaints (PQC) and Adverse Events (AE)

• Quality review and approval of Automation Incident investigations

Qualifications

 

Must possess working knowledge of Trackwise, SAP, Word, Excel and Power Point; good understanding of database concepts, theory and architecture; understanding and ability to perform metrics; working knowledge of and/or experience with Deviation/CAPA Management and Complaints/Adverse Event investigation systems from a Regulatory/Quality perspective is required. Electronic document control systems experience is highly desirable. Understanding of the FDA regulations and cGMPs with experience in document control and quality management in a highly regulated industry; experience in a high-volume, mission critical environment and excellent communication skills.

 

Must possess good analytical and problem solving skills, effective global communication skills (both written and oral), ability to multitask and manage multiple projects and deadlines, knowledge and understanding of database theory and design, with the ability to comprehend and utilize new technology, ability to adjust to changing priorities, and close attention to detail.

 

This position will report to the Associate Director, Quality Systems and Compliance.



Qualifications

Education Minimum Requirement:

  • BS degree in Engineering or Science

Required Experience and Skills:

  • Minimum 5 years of experience within in the Pharmaceutical industry in Quality, Technical, Manufacturing Operations, or related Business Operations working with Deviation Management, CAPAs,  Product Quality Complaints, and Adverse Event investigations
  • Experience performing review and approval of Deviations and CAPAs
  • Knowledge of cGMPs, data management collection and analysis
  • Proven expertise of cGMPs, technical writing, data management collection and analysis
  • Demonstrated Quality, Technical, and / or Manufacturing experience in the areas of Deviation Management, CAPAs, Product Quality Complaints, and Adverse Event investigations
  • Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence, and the ability to present to groups across the organization as needed
  • Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems
  • Demonstrated innovative mindset
  • Demonstrated cross cultural agility and resourcefulness
  • Proven expertise with Lean 6 Sigma methodologies

Preferred Experience and Skills:

  • Lean Six Sigma Green Belt or higher certification
  • Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance
  • Experience as Subject Matter Expert (SME) in presenting to regulatory agencies
  • Knowledge of Automation and ERP / Quality Data Management systems such as SAP, Trackwise, MIDAS, Emerson DeltaV, Allen Bradley PLC (or equivalent), MES (Manufacturing Execution System), and automated inspection systems
  • Quality Auditing experience
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.
  
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
 
Visa sponsorship is not available for this position.
 
For more information about personal rights under Equal Employment Opportunity, visit:
 
           
           


Job Quality GMP Related

Primary Location NA-US-NC-Durham-RTP

Other Locations 

Employee Status Regular

Number Of Openings 2

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