VMF Quality Batch Record Review Specialist
Location: Durham, North Carolina
Posted: January 21, 2017
Reference ID: QUA005491
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 Quality Assurance Coordinator is responsible for all Quality related functions that directly support the Durham Integrated Process Team (IPT) within VMF (Vaccine Manufacturing Facility) while actively supporting, participating in and embracing an empowered team culture. The IPT Quality Assurance Coordinator is responsible and accountable for Quality Assurance activities that support the VMF IPT, including review and approval of batch record documentation, along with review and approval of IPT related SOP's.
•Requires working knowledge and experience in the discipline; still acquiring higher-level knowledge and skills
•Builds knowledge of the company, processes and clients and/or customers
•Solves a range of straightforward problems
•Analyzes possible solutions using standard procedures
•Receives a moderate level of guidance and direction
•Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
•Understands the fundamental business drivers for the company; uses this knowledge in own work
•Understands and applies regulatory/ compliance requirements relative to their role
The IPT Quality Assurance (QA) Coordinator role will be responsible for activities that support cGMP and regulatory compliance during product manufacturing within the respective VMF IPT's to include the following:
•Direct in-line Quality support for all cGMP compliance, batch record review and approval
•Review and approval of batch record documentation (electronic batch record comment resolution, RT reports, autoclave records, review and approval of electronic and paper batch records as applicable).
•Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
•Author and review SOPs specific to the IPT
•SOP and CJA development and review
•Direct support of regulatory inspections and audits
•Direct support of validation activities and all other associated quality functions
•Other duties as requested by management
Education Minimum Requirement:
•Bachelor's Degree in Biology, Biochemistry, Chemistry or other relevant discipline
Required Experience and Skills:
•Minimum 3 -7 years experience in pharmaceutical operations, technical services, and/or quality operations with at least 2 years in a quality function or targeted training in quality to perform the defined responsibilities
Preferred Experience and Skills:
•Quality Control, Quality Assurance and/or cGMP experience
•Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry
•Experienced in the methods and approaches of conducting environmental monitoring
•Experienced in the methods and approaches of conducting quality audits
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.
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Visa sponsorship is not available for this position.
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