Specialist, Quality Control

Job Description

Essential functions include, but are not limited to:

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 moderate level of guidance and direction and also 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. 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. Good organizational and time management skills. Assists in direction of plant wide or department 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's Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements, including GMP, NOA, and related regulations, and has the ability to 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. Possesses strong technical writing capabilities and can compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc.

Possesses an advanced knowledge and ability to operate multiple instruments required to complete job responsibilities with the ability to generate data and reports from these instruments. Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures. Ability to independently respond to advanced requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change. Explains information and persuades others in straightforward situations. Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others. Makes decisions within guidelines and policies that impact own priorities and allocation of times to meet deadlines. Recommends scientifically sound corrective and preventive actions. Accountable for technical contribution to work or project team and may lead or manage a small project team. Requires little to no supervision.

                                                       

Primary activities include, but are not limited to:

• 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 experts.

• Works with other sites to ensure delivery schedules of samples to be tested are met.

• Supports and leads continuous improvement and supports sustainability of implemented changes.

• Identifies and implements continuous improvement changes within the laboratory.

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

• 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.

• Actively participates in Tier II and Tier Ill, as needed.

• Demonstrates in-depth knowledge of product performance and testing methodology.

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

• Responds to and remediates audit observations.

• Demonstrates in-depth knowledge of equipment and ensures proper usage of equipment occurs.

• Participates in coordination of testing activities within work team.

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

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

• Interprets compendia! 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).

• 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.).

• Revises laboratory procedures and authors quality notifications, as required.

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

• Leads remediation of walk thru audits obseNations 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, water, microbial limit testing, finished pharmaceutical products, and stability samples.

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

• 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.

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

• Performs any other work as assigned by Manager. 

​

Education Requirements

• B.A./B.S. degree (preferably in Science or Engineering)

Required Skills 

• Minimum of 3 years of pharmaceutical industry experience

• Knowledge of continuous improvement principles.

• Experience operating routine laboratory equipment including but not limited to: HPLC, dissolution apparatus, FTIR, NIR, Karl Fisher, pH meter, conductivity meter, UV, etc.

• Knowledge of regulatory and cGMP principles.

Preferred Skills

• Experience utilizing Empower.

• Experience utilizing Labware/LIMS.

• Execution of root cause analysis.

• Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications.

• Knowledge of Tier processes. Experience executing 5S principles.

Required Skills:

Accountability, Accountability, Adaptability, Analytical Instrumentation, Analytical Method Development, Communication, Customer Experience Improvement, Customer Service Improvement, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Lab Testing Equipment, Lean Six Sigma (LSS), Microbiological Analysis, Microbiological Test, Occupational Health and Safety Management, pH Measurement, Presentation Development, Quality Control Management, Quality Management, Service Improvement, Team Management {+ 4 more}

Preferred Skills:

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.

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

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

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”.

The salary range for this role is

$87,300.00 - $137,400.00

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:

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):

NA

Job Posting End Date:

04/18/2026

*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.