Merck Quality Assurance Coordinator-Latest Job Vacancy January 2015
Quality Assurance Coordinator Job
Date: Jan 14, 2015
Location: Wilson, NC, US
Quality Assurance Coordinator-QUA003896
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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 people 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.
We currently have a Quality Operations Laboratory Quality Assurance Coordinator (Stability and Release) vacancy at the Merck Facility in Wilson, North Carolina. The Wilson facility, located at the intersection of I-95 and US 264 Alternate, is a 500,000 square foot solid dosage / packaging site on 225 acres. The facility packages over 95% of physician samples in the U.S. market, including SINGULAIR®, FOSAMAX®, and MAXALT®, among many others. The facility has been in operation since 1983, and was recently selected as Merck's Packaging and Stability Centers of Excellence for North America. Wilson, NC is conveniently located approximately 2 hours from NC beaches and 45 minutes from the state capitol, Raleigh, NC. Wilson is home to Vollis Simpson's Windmill Farm, the only North Carolina Baseball Museum and the Wilson Botanical Gardens.
The Quality Operations Laboratory is a 40,000 square foot facility that provides support to the Wilson plant site operations through raw material and finished product testing and release; additionally, the Laboratory supports Merck & Co., Inc. on a worldwide basis through performing stability testing on finished products, API's and Components.
The Quality Assurance Coordinator (Stability) is an integral position for our worldwide Stability Laboratory that reports to the Stability Laboratory Manager. The Quality position manages the approval and disposition of stability and release samples.
Specific areas of responsibility include, but are not limited to the following:
- Manages annual summary reports for APIs and Finished Product Stability Studies.
- Responsible for management of projects, obtaining stability samples and starting stability studies.
- Responsible for approval/release of stability studies and laboratory data within LIMS.
- Responsible for approval/release of Raw Material and Finished Product laboratory data within LIMS.
- Responsible for writing study protocols based on the General Stability Protocol
- Responsible to trend/evaluate stability data per time-point and study.
- Develops/revises SOPs based on Merck policies/guidelines.
- Assists with laboratory investigations and integrates appropriately personnel into investigation meetings to determine root cause and path forward.
- Working knowledge of GMP, NDA, and related regulations. Ability to interpret those regulations for implementation in the workplace. Ability to interpret Merck Quality Policies/Guidelines for daily application. Knowledge and understanding of pharmaceutical operations systems
- Competencies/Leadership Behaviors/Skills: Position requires proficiency in the following competencies: Empowering leadership; Flexibility; Motivation; Functional Excellence; Teamwork/Collaboration; Results-Oriented; Problem-Solving; Communication.
- Scientific B.A./B.S.
- Minimum 4 years pharmaceutical industry experience preferably in stability release/management
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. Merck’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.
Search Firm Representatives - Please read carefully:
Merck 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.
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:Spclst, Quality Assurance
Primary Location: NA-US-NC-Wilson
Employee Status: Regular
Number of Openings: 1
Source : Merck career
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