Specialist, Quality Control

Job Description

Our Quality Control 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 delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities

• Completes a variety of analytical testing to support stability requirements for a variety of products

• Supports all areas of the QC laboratory, cross-training and providing testing support in various work cells

• Provides training to other teammates and serves as subject matter experts

• Works with our company's sites to ensure delivery schedules of samples to be tested are met

• Maintains compliance by following corporate policies/guidelines and local procedures

• Supports and leads continuous improvement projects with minimal assistance and works to ensure the sustainability of implemented changes identified through lean six sigma tools/activities

• Identifies and implements changes focused on improving compliance performance in the laboratory

• Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell

• Actively participates in Tier II as needed

• Demonstrates an in-depth understanding of product performance and testing methodology and able to train others on both

• Identifies proactive measures to ensure right first time achievement

• Leads remediation of walk-thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits

• Works cross-functionally to ensure proper prioritization/effective utilization of laboratory equipment

• Tests and interprets results for components, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples

• Interprets compendial and internal monographs, NDAs, CFR and our company's Quality Standards

• Ensures laboratory compliance by adhering to cGMP, CFR, EU, and other agency regulations

• Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements

• Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.)

• Maintains a safe workplace and identifies actions to prevent safety incidents in the laboratory

• Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance

• Provides guidance and coaching to new analysts within and outside his/her cell

Education Requirements

• Bachelor degree in Chemistry

Required Experience and Skills

• Minimum three (3) years of relevant work

• Knowledge of continuous improvement principles

• Operating routine laboratory equipment including but not limited to: HPLC, Karl Fisher, Drug Dissolution, pH meter, etc.

• Knowledge of regulatory and cGMP requirements

• Utilizing Empower or any other data acquisition software

Preferred Experience and Skills

• Managing Active Pharmaceutical Ingredients material testing

• Execution of root cause analysis

• Background in technical writing

• Knowledge of Tier process

• Executing 5S principles

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:

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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:

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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:R333395