Senior. Specialist, Quality Assurance

Employer
Merck
Location
Durham, NC, US
Posted
April 17 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007281

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. Position Description

 

The main functions of the Sr. Specialist, Quality Assurance is to assist in the review of batch records, evaluation of Quality Control (QC) data, investigations, support of operational excellence initiatives  as well as working to implement quality system initiatives and continuous improvements. 

 

Core Job responsibilities:

• Review of all final product release testing.

• Review of sterility confirmation/growth promotion testing of laboratory media and sampling.

• Supports the deviation management program including the coordination of managing Quality Notifications (QNs) in SAP to assess product impact and effective corrective actions and review of investigations.

• Serve as a technical subject matter expert (SME) in selected quality systems.

• Provides support to Production and QC activities by ensuring released  media and raw materials are available, including weekends as required.

• Executes Walkthrough audits of the GMP areas of the site on a routine basis.

• Executes review and approval of qualification documentation including Validation, IQ, OQ and PQ documents.

• Work closely with quality and other departments to ensure appropriate root cause and CAPAs are determined.

• Provide support to all Quality related audits from external and regulatory agencies.

• Execute and manage the Change Control workflow and Controlled Document change process and assess all changes prior to implementation. 

• Leads project teams ensuring delivery of results against established timelines.

• Identify Continuous Process Improvements to maximize efficiencies and streamline processes within the Quality systems.

 

  Qualifications

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.  

Position Qualifications

Education Minimum Requirement:  Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field

Required Experience and Skills**: Minimum of 6 years experience in pharmaceutical operations, technical services, and/or quality operations; Understanding and application of GLPs and cGMPs ; Experience with validated systems (GLIMS), and quality systems management; Experience working in a team environment

Preferred Experience and Skills: Strong verbal and written communication skills ; Prior experience in quality remediation activities


If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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:              EEOC Poster             EEOC GINA Supplement

Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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