Associate Specialist, Quality Control

Job Description

**POSITION OVERVIEW - Basic Functions & Responsibility **

Essential functions include, but are not limited to:

Employee must show ability to perform routine assignments and develops competence by performing structured work assignments. Ability to use existing procedures to perform routine testing. Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts. Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions. Builds and promotes the team's effectiveness through actions that demonstrate respect and appreciation for diverse perspectives. Demonstrates understanding of customer needs, requirements, and expectations. Seeks new ways to improve services to customers. Speaks up on tough issues and 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. Applies general knowledge of company business developed through education and past experience. Ability to interpret our company's Quality Policies, Guidelines and Testing Procedures for daily application. Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses a basic knowledge of theories, practices, and procedures in the Quality Control discipline, including the knowledge and understanding of pharmaceutical testing. Active with developing technical writing capabilities and is able to compile straightforward investigations and procedures and recommend scientifically sound corrective actions. Possesses a basic knowledge and ability to operate lab instrumentation required to complete job responsibilities. Uses existing procedures to perform routine testing. Ability to independently respond to basic requests for data and trending of data.

Communicates information and asks questions to check for understanding. Develops small scale presentations and presents to own work team or small groups with the assistance of others. Has limited decision-making authority and works within technical guidelines / direction to achieve objectives and meet deadlines. Accountable for technical contribution to work or project team.

Requires moderate to little supervision.

PRIMARY ACTIVITIES

Primary activities include, but are not limited to:

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1)**** Supports continuous improvement and supports sustainability of implemented changes. Identifies and implements continuous improvement changes within the laboratory.

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

3) Participates and leads, when required, Tier I and Tier II activities.

4) Demonstrates working knowledge of product performance and testing methodology.

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

6) Responds to and remediates audit observations.

7) Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs.

8) Participates in coordination of testing activities within work team.

9) Tests and interprets results for any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, & finished pharmaceutical products.

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

11)**** Interprets compendia! and internal monographs, NDAs, and our company's Quality Standards.

12) Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method

transfers, and API Stability Packaging Description (ASPD).

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

14) Revises laboratory procedures as required.

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

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

17) 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.

18) Performs any other work as assigned by Manager.

SKILLS (include specific skill levels to apply our company 's Leadership Principles):

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Education Requirements

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

Required Skills

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1) Knowledge of continuous improvement principles.

2) Experience operating routine laboratory equipment including but not limited to: Karl Fisher, pH meter, conductivity meter, UV, etc.

3) Knowledge of regulatory and cGMP principles.

Preferred Skills

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1) Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.

2) Experience utilizing Empower.

3) Experience utilizing Labware GLIMS.

4) Execution of root cause analysis.

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

6) Knowledge of Tier processes.

7) Experience executing 5S principals.

Required Skills:

Analytical Testing, Analytical Testing, Business Functions, Chemical Analysis, Detail-Oriented, GMP Compliance, GMP Laboratory, Laboratory Information Management System (LIMS), Lab Testing Equipment, Nondestructive Testing (NDT), pH Measurement, Preventive Action, Quality Control Inspection, Quality Control Management, Quality Engineering, Quality Improvement Programs, Quality Process Development, Quality Standards, Raw Materials, Regulatory Compliance, Standard Operating Procedure (SOP), Standards Compliance, Statistical Data Analysis, Teamwork, Technical Support {+ 1 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

The salary range for this role is

$65,100.00 - $102,500.00

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:

05/30/2026

***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. **