Sr. Specialist, Quality Assurance Job - United States
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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.
Works closely with Operations and Engineering in development and execution of Qualification and Validation of equipment, facilities and manufacturing processes. Represents Quality assurance and reviews and approves protocols and reports in support of above. Will support sites across the Midwest as well as Global support teams to develop and implement an aligned approach to Qualification and Validation processes. These projects include capital expansion and upgrades, support of existing equipment and processes. Must meet all in house and regulatory requirements for the Qualification and validation execution.
Education Minimum Requirement:
- Bachelor degree in Engineering or scientific field.
Required Experience and Skills:
- Minimum of 5 years’ experience in role of Qualification and Validation review and approval.
- Ability to monitor trends and recommend corrective actions to cease continued performance issues with equipment and processes.
- Able to assist with the compilation of agency responses in support of responsible activities.
- Provide Quality Assurance review and approval of all GMP-related SOPs.
- Ability to drive collaboration and engagement across functions both internally and externally to implement improvement.
- Ability to work independently with minimal guidance
- Act as a resource for colleagues with less experience within own discipline. Solves complex problems and takes a new perspective using existing solutions. Builds knowledge of the company, processes, and customers.
- Good organizational and time management skills.
- Has the ability to effectively manage multiple and changing priorities/projects and ensure timely completion.
Preferred Experience and Skills:
- Knowledge of sterile processes and biologic processes desired. Good communication and interpersonal skills.
- Proven ability to act as a team or project lead and leads work of others as required.
- Able to present data to others outside and internal working groups to gain consensus on appropriate path forward.
- Drives continuous improvement (business and compliance excellence) through the use of lean six sigma methodology and identification of improvement opportunities.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
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-NE-Elkhorn
Other Locations: NA-US-KS-DeSoto
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Omaha
Nearest Secondary Market: Council Bluffs
Job Segment: Law, Quality Assurance, Compliance, Engineer, Lean Six Sigma, Legal, Technology, Engineering, Management