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Quality Assurance Specialist

Requisition ID: QUA007933

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.

Merck Manufacturing Division, MMD, 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.

Position carries out a variety of activities to support production of a bioburden reduced vaccine intermediate product. The position must become familiar with site processes, procedures, and policies assuring alignment with cGMPs (current Good Manufacturing Processes) and Health Authority regulations. Conducts batch record reviews, audits, investigations, and helps with internal audits / external inspections. Performs quarantine functions and accountability reviews. Reviews and approves SOPs for production, cleaning, mainenance and utility support activities. Supports special projects as assigned. Follow cGMP and routinely makes decisions using cGMP/process knowledge. Works with customers to resolve problems and to satisfy quality and production needs. Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance. Follows site safety requirements. Authors, reviews, and or approves data and documents such as methods, procedures, and protocols. Completes assigned projects. Performs all work in a timely manner and is an active member of 1 or more teams. Tracks/reports metrics.

Qualifications

Education Minimum Requirement:

  • Bachelor's degree Scientific (biology, engineering, physics, psychology, engineering, other)

Required Experience and Skills:

  • 2 years experience in pharmaceutical industry or quality assurance/control
  • Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues. Interpretation of vague guidance for application in specific control systems and equipment
  • Demonstrated verbal/written communication and decision making skills
  • Experience with GMP/compliance requirements for food or pharmaceutical industry; technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding; sterile/aseptic processing experience
  • Act with Courage and Candor - demonstrated ability and willingness to advocate for compliance position using objective evidence
  • Collaboration - ability to maintain productive communication channels with stakeholders
  • Utilize several laboratory data, inventory, quality management, maintenance, and other computerized systems.
  • Learning agility - demonstrated ability to continually learn new technical, quality/compliance, & regulation knowledge and apply

Preferred Experience and Skills:
  • Demonstrated independent thinking
  • Knowledge of and experience in Quality Risk Management methods
  • Ability to prioritize and balance work from multiple projects in parallel
  • Working knowledge of manufacturing and utility systems, controls, and processes
  • Experience with mechanical, electrical, and P&ID drawings


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 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:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.

Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia

Quality Assurance Specialist

Elkton, MD 21921
Full Time

Published on 09/27/2018