Job Details

ID #50282953
State Pennsylvania
City Westpoint
Salary TBD
Source Merck
Showed 2023-09-19
Date 2023-09-19
Deadline 2023-11-17
Category Et cetera
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Senior Specialist, Quality - Environmental Monitoring

Pennsylvania, Westpoint, 19486 Westpoint USA
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Job DescriptionThe Environmental Monitoring Quality Senior Specialist 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 EM Quality Sr. Specialist 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. The EM Quality Sr. Specialist 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 Environmental Monitoring Quality Sr. Specialist 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.Key Job Functions:

Becomes fully trained in our Company Quality SOPs, production SOPs as needed, and SAP functions as required by EM Quality Specialists

Learns and adheres to current Good Manufacturing Practices, the manufacturing process, our Company Quality Systems, and safety procedures

Monitors environmental performance against specifications within classified areas

Provides environmental support to manufacturing and testing areas as needed

Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures

Actively participates in the Tier process and uses this forum to escalate concerns and best practices

Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans

Aids in, review, and approval of investigations into environmental excursions

Author, review, and approve routine and event-based environmental related project protocols and reports

Assists with training of incoming and existing personnel

Leads and develops a team of EM Quality Specialists with direct reporting structure

Cross trains 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 and regulatory inspections

Minimum Education Requirement and Experience:

Bachelor of Science (BS) degree in Chemistry, Engineering, Pharmacy, or equivalent with five (5) years of environmental monitoring, laboratory operations, or sterile/vaccine production setting

Master of Science (MS) degree in Chemistry, Engineering, Pharmacy, or equivalent with three (3) years of environmental monitoring, laboratory operations, or sterile/vaccine production setting

Required Experience and Skills:

At least 2 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

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:

Bachelor's degree in microbiology or biology is preferred

Familiarity with vaccine and/or pharmaceutical processing

Aseptic gowning may be required

NOTICE FOR INTERNAL APPLICANTSIn 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.Current Employees apply HERE ($1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE ($4020.htmld)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.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:EEOC Know Your Rights ( GINA Supplement​Pay Transparency Nondiscrimination ( are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts ( Hybrid Work ModelEffective 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 CarefullyMerck & 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:No Travel RequiredFlexible Work Arrangements:HybridShift:1st - DayValid Driving License:YesHazardous Material(s):N/aRequisition ID: R259288

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