Quality Assurance Senior Specialist Automation 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 Senior Specialist Quality Control will be a member of the Quality team providing guidance and approval of computer system validation projects. Responsible for effective documentation review and conformance to Merck Manufacturing Standards, Merck Manufacturing Division Quality Policies, and cGMPs for the generation of Quality Assurance Plans, Requirements specifications, Design Specifications, and Test Protocols. Also responsible for the evaluations of System Life Cycle practices for security and configuration management. Plans and coordinates multiple projects simultaneously.
Duties to include:
- Works in an empowered, self directed culture with a great deal of independent decision with input of leadership and colleagues. Will plan, coordinate and execution of multiple projects.
- Leads/mentors Quality Assurance team.
- Supports site for regulatory inspections related to automation compliance.
- Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.
- Responsible for effective document review and conformance to Merck Manufacturing Standards, MMD Quality Policies, cGMPs for the generation of Quality Assurance Plans, Requirements specifications, Design Specifications, and Test Protocols Coordinating and possibly performing in-process assessments of new systems and period inspections of existing systems.
- Trains user community on the application of best practices and pertinent (Systems Life Cycle) SLC topics.
- Develops site procedures and reviews updates to divisional guidelines.
- Responds to divisional computer validation initiatives and Quality Alerts.
- Responsible for updating and tracking document approval status and updating the Quality Automation Compliance Review / Approval database.
Education Minimum Requirement:
- Bachelor's degree in Science, Computer Systems, Engineering or equivalent
Required Experience and Skills:
- Minimum of 3 years experience in cGMP regulated industry supporting computer systems and computer systems validation.
- Experience in one or more functional areas such as quality assurance, quality control, manufacturing or engineering.
Preferred Experience and Skills:
- Experience with qualification of automation systems in a Pharmaceutical or Biotechnology environment is highly preferred
- Computer systems development methodology is preferred
- Technical writing experience in a cGMP environment
- Prior supervisory/management experience is a plus
- Skills in collaboration, and teamwork
- Strong leadership skills with the ability to effectively communicate with wide variety of customers.
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.
Search Firm Representatives Please Read Carefully:
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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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Qual Assurance & Ops Generic
Job Title:Sr. Spclst, Quality Assurance
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Betalactam Antibiotic – Must not have alleregy
Company Trade Name:Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia
Job Segment: Biotech, Law, Engineer, Pharmaceutical, Quality Assurance, Science, Legal, Engineering, Technology