Requisition ID: QUA008148
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations. The role will support facility and equipment qualification activities through review and approval of qualification activities, change control, procedures and other related quality systems changes. The successful candidate will conduct batch record reviews, self audits including aseptic audits, investigations, investigations review /approval and help with regulatory inspections. The role may support sampling requirements for several areas. May perform quarantine functions and accountability reviews.
Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge. May work with customers to resolve problems and to satisfy quality and production needs. May perform regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance. Follows site safety requirements. Authors, reviews, and or approves data, and documents such as methods, procedures, and protocols. The individual completes assigned projects as needed. Performs all work in a timely manner and is an active member of 1 or more teams. The individual tracks/reports metrics as needed. Supports aseptic operations including auditing of classified (Grades A/B/C) areas. Including getting certified for Grade A/B gowning.
Education Minimum Requirement: Bachelor's degree in Science or Health Science or Engineering or applicable experience in pharmaceutical or regulatory/health authority field. A degree in microbiology will be extremely useful in this role.
Required Experience and Skills: Previous Experience in Pharmaceutical Industry
Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/inspection role.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: Yes: Beta Lactam
Company Trade Name: Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia