Specialist, Quality Assurance 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.
Merck Sharp & Dohme Corp. is currently seeking candidates for the position of Specialist, Quality Assurance within the Complaint Investigation Team at its Wilson, North Carolina facility. The Wilson facility, located at the intersection of I-95 and US 264 Alternate, is a 500,000 square foot facility on 225 acres. As a Packaging Center of Excellence for Merck, the facility packages a variety of finished goods types for both domestic and international supply including secondary packaging of vial, syringe and inhaler configurations. The Wilson facility also includes one of Merck's Global Stability Centers of Excellence, which completes stability testing for active pharmaceutical ingredients and finished goods, which are manufactured and supplied around the world. The facility has been in operation since 1983, and is located in Wilson, NC.
Primary activities include, but are not limited to:
The primary responsibilities of the Specialist, Quality Assurance - Complaints include completion of customer complaint investigations partnering with Subject Matter Experts from various functional disciplines to identify root cause and appropriate corrective/preventative actions. This Specialist position must demonstrate solid leadership capability as demonstrated by, but not limited to, ensuring timely completion of investigation activities, establishing and maintaining knowledge and understanding of trends and changes within the production environment, as well as corrective action effectiveness. In addition, the Specialist position must be proficient in Root Cause Analysis tools, technical writing and data analysis to identify trends within received complaints. The Specialist is knowledgeable in both domestic and international regulatory requirements, and ensures site compliance with all expectations.
- Manages complaint investigations and investigational activities which may span multiple sites.
- Contributes to Field Alert Reports and BPDRs, as applicable.
- Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective action.
- Interprets Merck Quality policies, GMPs, and other agency regulations for application to the Wilson site.
- Complaint and production investigation root cause analysis and corrective action identification.
- Completion of documentation of investigations.
- Use of statistical methods in defect resolution.
- Interactions as SME with auditors/inspectors during internal/external GMP audits and regulatory inspections.
- Policy/procedure development and interpretation.
- Review and approval of GMP-related SOPs.
- Knowledge of equipment/process validation/qualification activities.
- Regulatory documentation review.
- Monitoring of performance through tracking and trending to ensure compliant operations.
- BA/BS Degree
- Degree field in science, technical operations or engineering preferred.
- Masters Degree in Regulatory Affairs, or equivalent.
- Minimum of 2 years of experience in a quality, operations, engineering or supply chain function.
- Working knowledge of packaging/pharmaceutical operations.
- Experience writing or supporting complaint/non-conformance investigations.
- Knowledge of regulatory requirements/cGMPs.
- Excellent written and oral communication skills (including technical writing).
- Experience in the development and management of metric/trend information.
- Excellent leadership skills, including collaboration and ability to identify and drive continuous improvement
- The candidate must also possess a high degree of problem solving ability (performance of root cause analysis) and have demonstrated ability to manage multiple priority projects/workload, ensuring timely completion.
- Knowledge of cGMPs and domestic and international regulatory requirements.
- Experience designing and implementing lean business processes.
- SAP system experience.
- Experience in Quality function that supports compliance activities within pharmaceutical manufacturing facility or other FDA regulated facility is preferred.
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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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.
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Job: Quality Operations
Job Title:Spclst, Quality
Primary Location: NA-US-NC-Wilson
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount
Job Segment: Engineer, Law, Quality Assurance, ERP, Pharmaceutical, Engineering, Legal, Technology, Science