Merck Quality Associate Specialist – Microbiology in Durham, North Carolina

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 Quality Operations Laboratory Analyst performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will initially be assigned to support the microbiology testing laboratories.

Microbiology Laboratory

The emphasis is on microbiological methods, such as sterility, bacteriostasis/fungistasis, Neomycin potency, Mycoplasma, and Mycobacteria.

The successful candidate:

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

• Authors standard operating procedures (SOPs) for the performance of laboratory methods

• Trouble-shoots equipment issues as needed

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions

• Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements

• Provides active support during audits and inspections (regulatory, internal, safety)

• Supports MMD divisional and Quality initiatives

Education Minimum Requirement:

  • Bachelor's degree in a science field required, preferably biology, microbiology, biological sciences

Required Experience and Skills:

  • Must have good technical writing skills and high attention to detail

  • 1-3 years laboratory testing experience or equivalent educational laboratory experience

  • Must be able to work independently and within a team environment

  • Must possess good communication skills

  • Aseptic Techniques

Preferred Experience and Skills:

  • Knowledge of cGMPs

  • Root cause analysis methodology

  • Experience in Compendia microbiological testing methods

  • Experience in analytical method transfer

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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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Quality Operations

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Quality Associate Specialist – Microbiology

Primary Location: NA-US-NC-Durham-RTP

Requisition ID: QUA006036