Senior Specialist - Change Control 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.
Ensures that all MSD products supplied by external manufacturers/partners (Contract Manufacturing Organizations, Contract Testing Labs, and/or Alliances) are manufactured, packaged, analyzed, released, stored and/or distributed in accordance with MSD expectations and all applicable regulatory requirements. Responsible for all change controls in the External Quality Assurance – Sterile platform. This includes managing regulatory pre-reads, creation and ownership of the change record, as well as guiding SMEs to complete actions in order to execute the change control with minimal to no supply interruptions. Supports implementation of change control policy supporting external manufacturers of API intermediates, API, non-sterile & sterile pharmaceuticals, biologics, drug delivery system and consumer care products, by means of a risk based quality oversight, support and technical advice and providing on-site supervision as appropriate.
Responsibilities include involvement or leadership in activities related to change management at external manufacturer/partner, permanent audit readiness, providing coaching and training were applicable to build effective change management system at the partner and supporting continuous improvement activities. The incumbent exercises a role in monitoring and maintaining the external manufacturers/partners compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements in accordance with Quality and Supply Agreement terms and Company Policy.
Education Minimum Requirement:
- Bachelor of Science degree ( BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent)
Required Experience and Skills:
- Must have a minimum of five years’ experience in the pharmaceutical industry.
- Strong interpersonal, relationship building and leadership skills.
- Must have good communication, negotiation and persuasion skills.
- Must be fluent in both spoken and written English.
- Must have one year experience in Trackwise.
- Strong understanding of GMP requirements.
Preferred Experience and Skills:
- Experience in Track wise change management including change owner.
- Minimum 2 years’ experience working in above site organizations.
- Strong problem solving skills.
- Able to demonstrate organizational skills and is self-motivated.
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-MA-Lexington
Other Locations: NA-US-NC-Durham, NA-US-VA-Elkton, NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Boston
Job Segment: Microbiology, Chemical Research, Pharmacy, Law, Pharmaceutical, Science, Engineering, Healthcare, Legal