Senior Specialist, Quality Systems Job - United States
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. 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 Quality Systems Senior Specialist, reports to the Associate Director, Quality Systems and supports development quality activities at the West Point Site. This position is critical to maintaining the clinical supply chain for investigational product. Specifically this position supports clinical investigations, clinical complaints, deviation management, change management records and Corrective Action Preventive Actions (CAPAs) associated with these events.
The area of focus for such events can be the manufacturing and testing of the clinical product. Areas of focus will be to undertake tasks as it relates to complex supply chains and supply types and conduct all work meeting high standards for quantity, integrity, quality and GMP compliance. This role also takes on the oversight for the Bio / Vaccine areas of analytical development as it relates to guidance in investigations for root cause analysis (RCA), Quality Risk Management (QRM) and defining CAPAs. This position also will be involved in metric creation and reporting for the Quality Systems in general to the Site Quality Council.
Responsibilities include, but are not limited to:
1. Manage, process and approve Investigations, CAPA extension requests and change management records
2. Review and approve critical Quality complaints and Investigation extensions
3. Support Audits (Health Authority, Internal, Divisional)
4. Share in the support of the PSQTS system responsibilities owned by the Quality System Team
5. Proactively identify, develop and implement areas for work process improvement and efficiency.
Education Minimum Requirement:
- B.S. in appropriate Science or Engineering discipline (chemistry, biology biochemistry, microbiology); advanced degree preferred.
Required Experience and Skills:
- Minimum 8 years experience in Pharmaceutical or related industry
- Experience in one or more fucntional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering
- Strong leadership skills for the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives
- Excellent verbal and written communication and presentation skills
- Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise, including EU requirements
- Computer skills; knowledge and competency in PowerPoint, Excel, and Word
- Ability to independently manage multiple priorities and projects
Preferred Experience and Skills:
- Previous GMP Quality role (quality Systems, validation, compliance, audit, assurance)
- Familiarity with R&D or clinical supply areas and processes
- Knowledge and competency in Trackwise
- Regulatory or QP inspections
- Superior skills in collaboration, teamwork, conflict management
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Clinical, Non Clinical Quality Assurance
Job Title:Sr. Spclst, Quality Assurance
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Engineer, Law, CAPA, Science, Engineering, Legal, Management