Assoc. Spclst, Quality

Merck & Co. • Durham, NC

261d • Onsite

About The Position

Our Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Requirements

• At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
• Evidence of good oral and written communication skills.
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.
• Ability to sit, stand and move within workspace for extended periods.
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling.
• Ability to lift to 50 pounds.
• Must pass a varicella titer prior to arriving for the first day on the job.

Nice To Haves

• EM Sampling in a pharmaceutical setting (not EPA) with GMP experience.
• Quality Control, Quality Assurance and/or cGMP experience.

Responsibilities

• Maintain the Environmental Monitoring (EM) program including collection and testing of qualified Utility systems such as Clean Steam, WFI, and compressed gases.
• Execute environmental sampling of Classified Areas including active air sampling, surface sampling, and non-viable air sampling.
• Provide data entry, review and approval as required.
• Provide summaries of test results to appropriate personnel as needed.
• Compile and evaluate environmental data for adverse trends.
• Directly support Performance Qualification activities.
• Perform routine monitoring of Personnel.
• Compile and author Annual Reviews.
• Author and summarize Re-qualification, Performance Qualification, and Special Study protocols.
• Perform monthly and weekly sample accountability.
• Submit LIMS sample rejections.
• Manage Equipment Calibration and Management.
• File data sheets and document control of logbooks.
• Perform other duties as requested by Management.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Associate degree