EM Specialist, Quality

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.

The Environmental Monitoring Specialist (EM Specialist) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. The EM Quality Specialist, with guidance from the EM Lead, ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The EM Quality Specialist is responsible for the review and evaluation of routine and per process environmental monitoring (EM) 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.

The EM Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned End to End (E2E). Specific responsibilities include but are not limited to the following:

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

Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

• Learns cGMPs, the manufacturing process, and our Company quality systems.

• Monitor environmental performance against specifications within classified areas.

• Provide 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.

• Adherence to SOPs, GMPs and safety procedures.

• Aid in investigations into environmental excursions.

• Author environmental project protocols and reports.

• Assists with training of incoming personnel.

Education Minimum Requirement:

• Bachelors Degree

Job functions are performed primarily on the production shop floor or at desk and in a team environment.

Cross trains to support other functional quality areas including but not limited to deviation management for environmental monitoring investigations, and inspection support. Supports Process Simulations as a Quality Aseptic Observer.

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.

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

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 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”.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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:R341450