"Alerted.org

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.

Responsibility for daily operation of laboratory including coordination of testing and data review to meet due dates. Participates in continuous improvements, lean activities, kaizens and other process improvement initiatives. Performs Quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products. Requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers. Receives a minimal level of guidance and direction and proactively seeks advice/information from others when addressing serious business issues that may impact other functions. Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals.

Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory. Speaks up on tough issues and occasionally challenges the status quo. Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas. Effectively balances own point of view with new information and the perspectives of others while addressing conflict among peers and/or team members. Works to develop new skills and abilities. Readily accepts performance feedback and incorporates this feedback into future performance. Assists other team members, including helping with developmental activities. Learns to use new problem-solving tools to surface and solve issues. Excellent organizational and time management skills. Assists in direction of plant wide or departmental objectives. Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory. Ability to interpret our Company Quality Policies and Guidelines for daily application.

Understands and applies regulatory/compliance requirements, including current Good Manufacturing Practice (cGMP), New Drug Application (NDA), and related regulations, and can interpret those regulations for implementation in the workplace. Possesses an expanded knowledge of theories, practices and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing and change control principals, solid technical writing capabilities with demonstrated ability to perform more complex investigations, procedural updates, audit responses, equipment qualification and development of validation protocols, etc.

Primary Responsibilities

+ Completes a variety of testing to support release and stability requirements for a variety of products.

+ Supports all areas of the laboratory, cross-training and providing testing support in various work cells as required.

+ Provides training to other teammates and serves as subject matter expert.

+ Maintains compliance by following corporate policies/guidelines and local procedures.

+ Identifies improvements to procedures and revises/trains others on the changes completed. Functions as departmental Change Control Coordinator/Task Owner.

+ Supports and leads continuous improvement projects with minimal assistance and works to ensure 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 1 Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell. Actively participates in Tier 2 and Tier 3, as needed.

+ Demonstrates in-depth understanding of product performance and testing methodology. Able to train others on both.

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

+ Ensures work is completed right first time. Performs root cause analysis and corrective action identification for deviation occurrences and properly documents investigations. 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.

+ Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limits testing, finished pharmaceutical products, and stability samples.

+ Interprets compendial and internal monographs, NDAs, Code of Federal Regulations (CFR) and our Company Analytical Standards.

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

+ 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.).

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

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

+ Provides guidance to new analysts within and outside their cell.

+ Performs Purified/Potable Water sampling and testing.

+ Performs Compressed Air Utility sampling and testing.

+ Performs Environmental Monitoring sampling and testing.

+ Supports GLIMS team as necessary.

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

Education Minimum Requirements

+ At least a Bachelor's degree in science or engineering.

Required Experience and Skills

+ Knowledge of continuous improvement principles

+ Minimum of five (5) years of pharmaceutical industry experience required

+ Technical Writing experience.

+ Experience with writing SOP's

+ Knowledge of federal and industry guidelines and regulations, and dealing with and/or responding to regulatory authorities.

Preferred Experience and 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

+ Prior supervisory/management experience.

Required Skills:

Accountability, Accountability, Adaptability, Aseptic Operations, cGMP Compliance, Code of Federal Regulations, Data Analysis, Documentations, Environmental Monitoring, Good Manufacturing Practices (GMP), IS Audit, Laboratory Techniques, Lab Testing Equipment, Lean Six Sigma (LSS), Motivation Management, Performance Feedback, Pharmaceutical Guidelines, Pharmaceutical Microbiology, Process Improvement Projects, Professional Integrity, Quality Assurance (QA) Standards, Quality Auditing, Quality Control Management, Quality Inspections, Raw Material Testing {+ 4 more}

Preferred Skills:

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”.

The salary range for this role is

$104,200.00 - $163,900.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/12/2025

*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:** R370006