Associate Specialist, Environmental Monitoring

Quality Assurance Analyst

Our Quality Assurance 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.

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 up to 50 pounds. The candidate must pass a varicella titer prior to arriving for the first day on the job.

Specific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following :

• Collection and testing of qualified utility systems including 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. Equipment calibration and management.
• Filing data sheets and document control of logbooks. Other duties requested by management.

In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM plates, TOC analysis, conductivity, biological indicators, KTA LAL, bioburden, growth promotion, micro-IDs, gas testing, LIMS, SAP, Trackwise, investigations with GMP experience.

Education minimum requirement : Bachelor's degree preferably in a science field.

Required experience and skills : At least 1 year of relevant post-degree work experience.

Preferred experience and skills : EM sampling in a pharmaceutical setting (not EPA) with GMP experience. Quality control, quality assurance and / or cGMP experience.

Our Manufacturing & Supply Division is committed to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. A federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights.

We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $63,900.00 - $100,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Regular employment status, no relocation, no visa sponsorship, 10% travel requirements, not applicable flexible work arrangements, 1st-day shift, no valid driving license required, hazardous materials include cleaning supplies and laboratory supplies.

Required skills : Adaptability, air sampling systems, analytical problem solving, aseptic manufacturing, biopharmaceuticals, data analysis, environmental monitoring, environmental monitoring systems, GMP compliance, laboratory instrumentation, laboratory operations, laboratory testing, pharmaceutical microbiology, quality assurance (QA), quality assurance (QA) standards, quality control inspection, quality control management, quality management, raw material testing, teamwork, technical writing.

Preferred skills : [Not specified]

Job posting end date : 07 / 3 / 2025. A job posting is effective until 11 : 59 : 59PM on the day before the listed job posting end date. Please ensure you apply to a job posting no later than the day before the job posting end date.