Sr. Specialist, Quality 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.
The Sr. Specialist, Quality is a leadership position that provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. With guidance from the IPT Quality Leadership team, the Sr. Specialist, Quality will lead a team of 2-4 Specialists that ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The Sr. Specialist, Quality is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas and utilities. This position also works closely with the assigned End to End (E2E) in a team environment to ensure timely completion of responsibilities with emphasis on right first time.
The Sr. Specialist, Quality will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned End to End (E2E). Specific responsibilities include but are not limited to the following:
•Becomes fully trained in Merck Quality SOPs, production SOPs as needed, and SAP functions as required by EM Quality Specialists.
•Learns cGMPs, the manufacturing process, and Merck quality systems.
•Monitor environmental performance against specifications within classified areas.
•Provide environmental support to manufacturing and testing areas as needed.
•Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures.
•Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
•Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
•Adherence to SOPs, GMPs and safety procedures.
•Aid in investigations into environmental excursions.
•Author environmental project protocols and reports
•Assists with training of incoming personnel.
•Leads team of EM Quality Specialists with direct reporting structure.
• Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support.
Required Experience and Skills:
- Bachelor's degree in Microbiology or Biology is preferred. Candidates with BS in Chemistry, Engineering, Pharmacy, or equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting
- A minimum of 2 years of relevant work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
- Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Attention to detail, flexibility and an awareness of production and attendant quality control problems.
- Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.
- Demonstrated leadership capabilities
- Familiarity with vaccine and/or pharmaceutical processing.
- Aseptic gowning may be required.
Note: Titers may be required.
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.
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Job: Quality Operations
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck