Associate Specialist, Environmental Monitoring
Associate Specialist, Environmental Monitoring
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Job Description
Job Description
Job Description
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 (i.e. effective presentation of concepts and ideas as well as interpersonal and conflict resolution 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:
Bachelors 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
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.
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 thats committed to delivering a high quality reliable supply to customers and patients on time every time.
#EBRG #VetJobs
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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 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:
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 anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The salary range for this role is
$63900.00 - $100500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Cleaning Supplies Laboratory SuppliesRequired 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 WritingPreferred Skills:
Job Posting End Date:
07/3/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Employment Type
Full-Time
