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Job Description

Responsibilities:

+ Performs Purified/Potable Water sampling and testing.

+ Performs Compressed Air Utility sampling and testing.

+ Performs Environmental Monitoring sampling and testing Supports GLIMS as necessary.

+ Performs Microbial Enumeration Testing per USP <61> & <62>.

+ Performs any other work as assigned by Manager.

+ Tests and interprets results for any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples.

+ Participates in project activities designed to improve the business operation of the laboratory, the compliance posture of the laboratory, the skills and capabilities of the laboratory, etc. Supports continuous improvement and supports sustainability of implemented changes. Identifies and implements continuous improvement changes within the laboratory.

+ Ensures work is completed right first time. Participates in root cause and corrective action identification and documents investigations.

+ Participates and leads, when required, Tier I and Tier II activities.

+ Provides an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.

+ Responds to and remediates audit observations.

+ Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs.

+ Participates in coordination of testing activities within work team.

+ Maintains compliance by following corporate policies/guidelines and local SOP's.

+ Interprets compendial and internal monographs, NDAs, and our Company's Quality Standards.

+ Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).

+ Assures laboratory compliance by adhering to cGMP, CFR, and other agency regulations.

+ Revises laboratory procedures as required.

+ Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.

+ Maintains 5S organization throughout the laboratory and identifies improvement opportunities.

Education Requirements

+ B.A./B.S. degree (preferably in Microbiology or Science)

Required Skills

+ Knowledge of continuous improvement principles

Preferred Skills

+ Root cause analysis Background in technical writing Experience applying 5S concepts Experience operating routine laboratory equipment including but not limited to: pH, TOC/CONDUCTIVITY, Biological Safety Cabinets etc Experience with SAP/Trackwise

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Chemical Analysis, Continual Improvement Process, Data Analysis, Driving Continuous Improvement, Environmental Monitoring, Karl Fischer Titrations, Laboratory Analysis, Laboratory Information Management System (LIMS), Laboratory Instrumentation, Laboratory Maintenance, Laboratory Safety, Laboratory Techniques, Management Process, Microbiology Research, Parasitology, Pharmaceutical Guidelines, Pharmaceutical Microbiology, Raw Materials, Regulatory Compliance {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/5/2025

*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:** R349443