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Posted: Tuesday, March 14, 2017 9:22 AM

Senior Quality Specialist:QUA005671
Description
Merck and 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. Today, we are building a new kind of healthcare company : one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Senior Quality Specialist, with guidance from the Integrated Product Team (IPT) Quality Operations Leader or E2E Quality Operations Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. The Senior Quality Specialist ensures all necessary documentation (CRs, IQ/OQs, PQs, etc.) is approved, valid, and complies with all Regulatory and MMD requirements. This person is responsible for working closely with the various groups within the assigned IPT or E2E in a team environment to enable the timely release of product to the marketplace.
Primary Activities include, but are not limited to:
1. Manages aspects of the material control and/or release process as it relates to control of material for investigations and risk processing.
2. Responsible for compliance to cGMPs on the shop floor for assigned IPT or E2E.
3. Collaborates with personnel in Operations, Technology, and Planning to resolve issues, support investigation completion and approval, provide recommended production dispositions and corrective actions where appropriate.
4. Performs review and approval of quality notifications for assigned IPT or E2E.
5. Performs review and close:out of CAPAs and QCTS commitments within assigned IPT or E2E.
6. Performs review and completion for Change Requests for assigned IPT or E2E.
7. Performs review and approval of IQ/OQ/PQ for assigned IPT or E2E.
8. Performs, as necessary, review and approval of Environmental Monitoring qualification/ requalification/verification protocols and final reports for assigned IPT or E2E.
9. Performs GMP walkthrough inspections within IPT or E2E to ensure compliance with cGMPs and regulatory requirements.
10. Supports risk processing of material within the IPT or E2E through collaboration with Operations, Technology, and Planning.
11. Performs review and approval of Master Batch Records (MBRs), LIMS CRs, ACRs, etc.
12. Supports the preparation of regulatory filings by providing data and review, as required.
13. Maintains a broad:based knowledge of GMPs, Merck Manufacturing Policies, Guidelines and Procedures, regulatory guidance, evolving regulatory trends, and the working mechanics of MMD. Provides guidance to Operations and/or Laboratory Operations on quality issues based upon experienced and mature judgment and utilizes strong interpersonal skills to work with a diverse group of personnel in handling non:routine issues.
14. Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
15. Represents Quality on assigned project teams and leads those projects relevant to Quality within the IPT or E2E. Develops/updates systems on the aspects of material control/product release/shop floor compliance/deviation management within the established policies and guidelines. Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives. Responsible for acting as the quality representative on capital projects.
16. Leads/supports administrative activities

Source: https://www.tiptopjob.com/jobs/64851850_job.asp?source=backpage


• Location: Philadelphia

• Post ID: 37592486 philadelphia
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