Senior Specialist, Packaging Quality Operations Job
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.
Primary Activities include, but are not limited to:
- Manages aspects of the material control and/or release process as it relates to control of material for investigations and risk processing.
- Responsible for compliance to cGMPs on the shop floor for assigned IPT or E2E.
- 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.
- Performs review and approval of quality notifications for assigned IPT or E2E.
- Performs review and close-out of CAPAs and QCTS commitments within assigned IPT or E2E.
- Performs review and completion for Change Requests for assigned IPT or E2E.
- Performs review and approval of IQ/OQ/PQ for assigned IPT or E2E.
- Performs GMP walkthrough inspections within IPT or E2E to ensure compliance with cGMPs and regulatory requirements.
- Supports risk processing of material within the IPT or E2E through collaboration with Operations, Technology, and Planning.
- Performs review and approval of Master Batch Records (MBRs), LIMS CRs, ACRs, etc.
- Supports the preparation of regulatory filings by providing data and review, as required.
- 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.
- Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
- 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.
- Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for assigned IPT or E2E.
- Acts as a liaison with the Laboratory to prioritize the testing of samples to meet supply and schedule adherence needs and to work with the laboratory on optimization of cycle times.
- Provides training to incoming personnel and ensures compliance with departmental procedures.
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.
Required Experience and Skills:
•B.S., in appropriate scientific/engineering field
•Minimum of 5 years experience in a Quality Control, Quality Assurance, Manufacturing, Operations, Technology environment
•Demonstrated analytical, problem-solving and communication (oral/written) skills are required.
•Strong understanding of regulatory requirements and cGMPs
•Demonstrated leadership competence.
Preferred Experience and Skills:
•Experience with Deviation Management, Change Requests, and/or Customer Complaints is strongly preferred.
•Experience in batch release.
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Visa sponsorship is not available for this position.
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Job: Quality Operations
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck