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Specialist, Quality Operations Environmental Monitoring

3 months ago

Durham, North Carolina, United States Merck Full time

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 deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

At least 3 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.

Position Description: Specialist, Quality Operations Environmental Monitoring

  • 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 GLIMS 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, QN initiations and investigations, Trackwise, Change Controls, assisting with audits as an SME, writing and closing QN and QSAT CAPAs, with GMP experience.

Shift: Available for shift work, 4 - 10hr shifts (Wed-Sat) 4:00pm - 2:30am

Position Qualifications:

Education Minimum Requirement:

  • Bachelor Degree of Science in Biology, Microbiology, Chemistry, or similar field of study.

Required Experience and Skills:

  • At least 3 years 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.
  • Strong 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 work space 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.

​Preferred Experience and Skills:

  • Quality Control, Quality Assurance and/or cGMP experience.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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".

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

waste

Job Posting End Date:

07/28/2024

*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.

Job Posting End Date:07/28/2024

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.

Requisition ID:R299147