Quality Specialist - Environmental Monitoring
The Quality Environmental Monitoring Quality Specialist reports to the EM Quality Lead and provides direct Quality support to production areas as part of a Quality Integrated Production Team (IPT) Operating model for applicable assigned IPTs and with guidance from the Integrated Production Team Quality Leadership team, the Quality Specialist will ensure products/processes quality and perform activities to facilitate the release of product to the marketplace.
- Accountable for review and evaluation of routine, requalification, and qualification environmental monitoring sampling of classified areas and utilities | Works closely with the assigned End to End (E2E) operational and deviation management (DM) representatives in a team environment to ensure timely completion of duties with emphasis on right first time
- Accountable for performing job functions that are located in both classified production areas and within office settings
- Knowledgeable in Federal and other regulatory agency requirements and cGMP (Current Good Manufacturing Practices) to assure that all areas operate in a state of compliance
- Learns and adheres to current Good Manufacturing Practices, the manufacturing process, our Company Quality Systems, and safety procedures
- Learns and adhere to Standard operating procedural requirements of ensuring full compliance to data integrity
- Actively supports and/or participates in internal audits and regulatory inspections | Assists with ongoing inspection readiness state, ensuring areas are operating in a compliant and high-quality manner
- Accountable for actively contributing to and meeting all safety related expectations
- Becomes fully trained and maintains compliant state with Company Quality Standard Operating Procedures (SOPs), production SOPs, and Systems Applications and Products (SAP) functions as required by EM Quality Specialists
- Responds to potentially impactful environmental events in classified areas; these workstreams are associated with unplanned workstreams that warrant immediate cross-functional partnership, going into classified areas to evaluate, project management, creating testing schedules, evaluating and reporting on testing results, and finalizing projects
- Authors, reviews, and/or approves routine, event-based, and special study related environmental related project protocols, reports, and data assessments
- Aides in review of daily Out of Specification Report and works within the deviation management systems to address environmental excursions; this includes attending DM Tier meetings, working with operations to evaluate events, participation in deviation investigative processes, corrective and preventative action development, routinely going to the shop floor for evaluation, and other associated tasks
- Manages projects for process simulations in applicable manufacturing areas
- Risk based assessments and test site location map reviews and updates
- Authors and manages process and data related change requests
- Conducts Quality review/approval of new and updated SOPs and Controlled Job Aids
- Manages required data assessments for classified areas and can generate datasets, read, comprehend, and analyze data, results, and trends
- Monitors and assesses environmental performance against specifications within classified areas, as warranted, with respect to assigned workstream
- Authors and manages special studies and data assessments in support of operational deviations and associated investigations
- Provide environmental assistance to manufacturing and EM testing group; this includes working within the classified areas on routine basis
- Assists with training and coaching of incoming personnel and cross functional personnel
- Cross trains to assist other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support
Education Minimum Requirement:
- Bachelor's degree (firm) in Microbiology, Biology, Chemistry, Technology, or other related scientific areas of study.
Required Experience and Skills:
- 2- 5 years of pharmaceutical quality experience.
- Experience in deviation management
- Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Preferred Experience and Skills:
- Experience working with Laboratory Information Management Systems
- Technical Writing knowledge
- Project Management 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.
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
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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:
We 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.
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.
No Travel Required
Flexible Work Arrangements:
1st - Day
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