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Merck & Co. - Durham, NC
posted 2 months ago
About the position
The Associate Specialist in Quality Operations for Environmental Monitoring is responsible for maintaining the Environmental Monitoring (EM) program, which includes the collection and testing of utility systems, environmental sampling, data entry, and evaluation of environmental data. The role supports performance qualification activities and requires the candidate to perform routine monitoring and compile annual reviews, protocols, and sample accountability. The position involves shift work and may require additional off-shift tasks.
Responsibilities
- Maintain the Environmental Monitoring (EM) program including collection and testing of qualified utility systems.
- 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.
- Compile and evaluate environmental data for adverse trends.
- Support Performance Qualification activities directly.
- Compile and author Annual Reviews as required.
- Author and summarize Re-qualification, Performance Qualification, and Special Study protocols as required.
- Perform monthly and weekly sample accountability.
- Submit LIMS sample rejections.
- Manage equipment calibration and documentation control of logbooks.
- Perform other duties as requested by management.
Requirements
- Bachelor's Degree in Biology, Microbiology, Chemistry, or a similar field of study.
- At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations.
- Good oral and written communication skills, including effective presentation and interpersonal skills.
- Attention to detail, flexibility, and awareness of production and quality control problems.
- Strong understanding of GMPs and regulatory requirements related to vaccines and sterile pharmaceuticals.
- Ability to sit, stand, and move within the workspace for extended periods.
- Ability to perform repetitive tasks including frequent hand manipulations and lifting up to 50 pounds.
Nice-to-haves
- Quality Control, Quality Assurance, and/or cGMP experience.
Benefits
- Equal Opportunity Employer
- Commitment to inclusion and diversity in the workplace
- Hybrid work model for office-based positions
- Support for candidates needing accommodations during the hiring process
