Senior Specialist, Quality | Environmental Monitoring
The Environmental Monitoring Quality Senior Specialist (EMQSS) is a leadership position that provides direct Quality support to a production area as part of a Quality Integrated Production Team operating model. With guidance from the IPT Quality Leadership team, the EMQSS will lead and develop a team ranging from 1-3 EM Quality Specialists that ensures product/process quality and performs activities to facilitate the release of product to the marketplace and is responsible for the review and evaluation of routine and per process environmental monitoring sampling of classified areas and utilities. This position also works closely with the assigned End to End (E2E) in a team environment to ensure timely completion of responsibilities with emphasis on right first time. Job functions are performed primarily on the production shop floor and in a team environment.
The EMQSS will become knowledgeable in Federal and other regulatory agency requirements and Good Manufacturing Practices to assure that all areas operate in a state of compliance and will train on and gain competency in their responsibilities for assigned E2E.
- Become fully trained in company Quality SOPs, production SOPs as needed, SAP, and GLIMS functions as required by EM Quality Specialists
- Learn and adhere to current Good Manufacturing Practices, the manufacturing process, company Quality Systems, and safety procedures
- Monitor environmental performance against specifications within classified areas
- Provide environmental support to manufacturing and testing areas as needed
- Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensure compliance with departmental procedures
- Actively participate in the Tier process to inform, escalate concerns, collaborate across teams, and share best practices
- Collaborate with IPT members in the identification and implementation of continuous improvement initiatives and action plans
- Aid in review and approval of investigations into environmental monitoring excursions
- Aid and participates in aseptic process simulations
- Author, review, and approve routine, non-routine, and event-based environmental related project protocols and reports
- Assist with training of incoming and existing personnel
- Lead, coach, and develop a team of EM Quality Specialists with direct reporting structure
- Cross train to support other functional quality areas including but not limited to deviation management (i.e. environmental monitoring investigations) and change requests
- Actively participates within and provides support with internal audits and regulatory inspections
Education Minimum Requirement and Experience
- Bachelor’s Degree of Science (BS) in Science, Engineering, or related areas of study and five (5) years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations
Required Experience and Skills
- Evidence of good verbal 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
- Demonstrated leadership capabilities.
Preferred Experience and Skills
- Familiarity with vaccine and/or pharmaceutical processing
- Aseptic gowning
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.
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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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:Hybrid
Shift:1st - Day
Valid Driving License:Yes