Specialist - Quality Assurance

Employer
Merck
Location
West Point, PA, US
Posted
May 17 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007300

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. The Specialist - Quality Assurance will be a part of the West Point Quality Line Oversight team supporting the production shop floor in our four vaccine filling/inspection and packaging departments at the West Point, PA site.
This role in Merck Quality assures that products manufactured comply with cGMPs, operating procedures, and other applicable regulations. The incumbent will: 
  • Effectively collaborate with a work team, motivating others, ensuring performance, schedule execution, and task coordination.

Because our business is dynamic and advances in science and technology require new methods of production we are looking for individuals who can do the following: 
  • Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans. 
  • Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence and lean practices.
  • Must be capable of independently coordinating and completing optimization activities, in a multi-shift, shared ownership environment. 
  • Utilize lean principles and six sigma methodology to solve problems, and develops these problem solving skills in work teams. 
  • Facilitate implementation of corrective actions to correct past performance, proactively identify safety and quality-related trends, and be responsible for initiating actions to prevent issues from reoccurring. 
  • Recognize and investigate opportunities for financial savings. 
  • Understand lean principles and applies these concepts to all aspects of the production environment. 
  • Due to the high impact nature of this role it is essential that the incumbent demonstrate integrity, credibility and flexibility in their daily performance so as to motivate others to do the same.
  • Assure compliance with safety and environmental practices, cGMPs and SOPs in the work area. 
  • Participate in external and internal audits and inspections. 
  • Work with members from Operations and Technical Operations to properly handle unplanned events. Ensure that corrective actions are implemented.
  • Support other areas in Quality Assurance as needed 
  • In order to provide 24/7 coverage across all of our manufacturing areas, some off-shift and weekend coverage will likely be required.
  • Will be required to enter core sterile manufacturing area. 
 Qualifications

Education Minimum Requirement: 
  • Required: B.S. Degree in Engineering or Sciences
Required Experience and Skills**: 
  • Minimum of 1.5 years of experience in a heavily regulated industry (ex. FDA, Military, Nuclear, Petro-Chemical) OR a minimum of a Bachelor’s degree
  • Willingness to work alternate shifts and weekends
  • Ability to focus on and obtain results
  • Good verbal and written communication skills 
  • Ability to effectively collaborate within and across an integrated manufacturing team
  • Ability to enact conflict resolution
  • Ability to effectively respond to change
  • Excellent analytical and organizational skills
  • High personal integrity, credibility and energy
  • Flexability to perform related tasks to support the business
  • Computer literacy in MS Office, Word, Outlook, Excel

Preferred Experience and Skills:
  • Minimum 2 years working experience in cGMP pharmaceutical environment
  • Experience using Lean/Six Sigma tools

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:              EEOC Poster             EEOC GINA Supplement

Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck

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