Quality Assurance Specialist, Annual Product Review Supplier Management Job

West Point, PA, US
June 22 2017
Organization Type
Quality Assurance Specialist, Annual Product Review Supplier Management-QUA005979


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.

The Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as general End-to-End Support, Product Quality Complaints & Adverse Events, Market Actions, Internal Auditing, Training, Annual Product Review, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, and Risk Management in order to maintain compliance with Regulatory requirements. The individual has a key role in the execution of WP Site and MMD priorities. The Quality Specialist is responsible for execution of activities within their assigned areas. The individual is responsible for the execution of Quality Systems at the West Point site in accordance with cGMPs and international regulations, Merck guidelines, procedures, and policies. In addition, the individual is expected to identify and implement continuous improvement activities in their assigned area.

Primary activities include, but are not limited to:

• Processing of customer complaints received against finished products including handling of returned customer complaint samples.

• Perform Adverse Event investigations and support compilation and analysis of PQC and AE data for Complaint Unit business processes.

• Support Market Action activities including BPDR/FAR submission, Fact Finding, and Recall

• Authoring Annual Product Reviews (APRs).

• Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site.

• Providing Quality oversight of supplier information across all categories of suppliers that service WP.

• Run queries / reports / metrics in support of business processes

• Update Standard Operating Procedures (SOPs) related to these business processes as needed.

• Participate/support compliance projects to sustain and/or enhance compliance

• Participate/support projects to enhance efficiency and effectiveness

• Support ad-hoc data requests and analysis

• Author, review, and approve procedures and other control documents.

• Assist with aspects of Regulatory Inspections and commitments

• Participate in internal audits and shop floor inspections

• Performing gap analysis and remediation

• Quality Support/ownership for applicable automation systems

• Regulatory surveillance

• Conduct training on compliance topics

• Execute projects as required by the Associate Director

Individual may have the opportunity to support other areas within the MMD West Point Quality

Assurance organization, including:

*SOP and Batch Record Management

*Process Change Management

*CAPA Management

*Audits and Inspections

*Automation Compliance

*Deviation Management

*Inspection Management, QMS / Quality Council Management

*Quality Risk Management


Education Minimum Requirement:

- Bachelors degree in life science, scientific discipline or engineering preferred.

- Bachelor's degree in another discipline with a minimum of six (6) years experience working in a GMP environment, direct experience with Documentation Review and/or Control, or prior experience supporting Regulatory Agency Inspections.

Required Experience and Skills:

- B.S. Degree and a minimum of two (2) years experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

- B.A. degree and a minimum of years (6) years experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

Preferred Experience and Skills:

- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.

- Demonstrated analytical aptitude, critical thinking skills, and problem solving.

- Demonstrated ability to upskill / coach others.

- Strong written and verbal communication skills.

- Experience in pharmaceutical laboratory operations or related environment.

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:

EEOC Poster

EEOC GINA Supplement​

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

Job: Quality Operations

Job Title:Spclst, Quality

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

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