Senior QA Project Analyst Job Elkton 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.
Responsible for maintaining cGMPs for assigned areas at MMD Elkton, in conformance with Merck policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations.
This includes responsibility for the release of manufactured products, including intermediates, APIs, sterile products, vaccines, biologicals and materials for clinical trials (as applicable). As well as control of materials via release, restricted release, rejection, quarantine or administrative hold as applicable.
The incumbent will be responsible for approval of all of the assigned areas deviations, change controls and annual reports. As well as oversight of all manufacturing documentation including batch record review, maintenance work orders, forms, SOPs, training records and validation protocols and reports.
He/She will be expected to maintain contemporary knowledge of cGMPs for all major markets as well as MMD Policies and Guidelines.
Based on this he/she will provide quality support to the site, including training and guidance on the interpretation and implementation of MMD Guidelines/Policies and regulatory requirements. Responsible for a staff and adhering to approved budget.
Education Minimum Requirement:
- Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or equivalent
Required Experience and Skills:
- a minimum 5 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations
Preferred Experience and Skills:
- Communication and decision making: Ability to communicate with all levels of site and MMD organization via all means (written, verbal, presentations, etc.).
- Strong decision making skills.
- Ability to work/interact with off-site customers.
- Demonstrated experience in these areas is required.
- Detailed knowledge of areas impacting direct area of responsibility.
- Proven ability to lead self-directed teams.
- Demonstrated ability to manage complex projects.
- Strong contemporary knowledge of relevant cGMPs and regulations and current industry trends.
- Demonstrated knowledge of Site and MMD Business and Quality systems.
- Experience in all of the competencies is required.
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 email@example.com.
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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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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Assoc. Dir, Quality
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: biological manufacturing process
Company Trade Name:Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia
Job Segment: Microbiology, Quality Assurance, Scientific, Engineer, Law, Science, Technology, Engineering, Legal
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