Merck Specialist, Quality Assurance (Quality Systems Improvement Program) in West Point, Pennsylvania

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.

Reporting to a West Point Quality System Improvement Project (QSIP) Associate Director on the team, this role has responsibility for supporting the QSIP workstream deployment through managing logistics, assisting with gap assessments, reviewing documents, and tracking CAPAs. The successful candidate, as an integral member of the site QSIP team, will assist site workstream leads to build and/or improve the sitewide Quality Management programs in accordance with initiatives driven by the Divisional QSIP. Work is primarily achieved through project teams and partnership with site sub-system owners (SSOs) and site subject matter experts. This role will require working cross functionally with Operations, Technology, and Quality. There is an opportunity for one individual to primarily support Quality Risk Management initiatives at the West Point site where responsibilities would include management of the site quality risk register and coordination of risk review activities.

Primary activities may include, but are not limited to:

  • Work in an empowered culture with a moderate level ofguidance and direction.

  • Assist Communications lead with creating and deployment ofsite and global level communications.

  • Assisting Work stream leads in deployment of site-basedtraining to personnel impacted by Quality System enhancement initiatives

  • Assist SMEs in collating comments, updating, reviewing, andcirculating procedures for approval.

  • Apply team effectiveness skills, listening, and integratingdiverse perspectives from across the workgroup; contributes and adds value tothe achievement of goals.

  • Solve a range of straightforward problems.

  • Participate on teams supporting internal functions and/orevaluating site processes for improvement opportunities.

  • Provide information for regulatory inspections as needed.

  • Potential opportunity to support other areas within MMD West Point Quality Assurance.

  • One individual will have the opportunity primarily supportQuality Risk Management (QRM) where activities include:

  • Maintain site quality risk register.

  • Report site QRM metrics and status to the site and appropriateglobal groups.

  • Coordinate residual risk reviews.

  • Coordinate schedule-based risk reviews.

  • Aggregate QRM Risks based on common hazards or causes andsupport transfer of aggregated quality risk information to Integrated RiskManagement (IRM) Site Risk Register

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.

Education Minimum Requirement:

  • A minimum of a Bachelor’s degree isrequired.

  • A degree focused in Science,Engineering, or Business is preferred.

Required Experience and Skills:

  • A minimum of 3 years in GMPManufacturing environment, Pharmaceutical/Biological Quality, Operational, orTechnical function supporting manufacturing or testing operations, or relatedindustry experience in a laboratory, manufacturing, science related orregulated setting.

  • In-depth working knowledge and applicationof GMPs and/or GLPs.

  • Strong and effective communicationskills (both written and oral).

Preferred Experience and Skills:

  • Quality Risk Management experience is aplus.

  • Hands on experience with CAPAs and SOPrevision is a plus.

  • Demonstrated interpersonal skills includingflexibility, collaboration and inclusion skills, and ability to work in a teamenvironment.

  • Experience with process improvements.

  • Proven analytical aptitude, criticalthinking skills, and ability to apply key concepts.

  • Speaks with courage and candor.

  • Proven ability to manage multipleprojects simultaneously.

  • Strong customer service focus.

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:

EEOC Poster at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Qual Assurance & Ops Generic

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Specialist, Quality Assurance (Quality Systems Improvement Program)

Primary Location: NA-US-PA-West Point

Requisition ID: QUA006325