Assoc. Spclst, Quality Control

Job Description

Associate Specialist, Quality Control (In-Process Control Lab)

The position of Associate Specialist in In-Process Control Lab will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.

In this role, you are required to perform shift work (12 hours rotating shift (day/night) including Sat/Sun and will be responsible for all or subset of the key responsibilities below:

Responsibilities

• Performs analytical testing and review/ release, of in-process samples, cleaning samples, utility systems, intermediates and finished drug substances according to approved procedures.

• Ensures tests assigned are performed in a timely manner in compliance to test methods and standard operating procedures with necessary laboratory safety precautions

• Participates in analytical method transfer, validation, verification, new product introduction, and equipment qualification.

• Assists in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.

• Participates in Laboratory safety and/or compliance walkthroughs and respond to regulatory, compliance, and audit related matters, where applicable.

• Provides input for the development and revision of Analytical Standards, Standard Operating Procedures, Work Instructions, and other GMP documents.

• Maintain proper laboratory housekeeping, laboratory inventory, and ensure inspection readiness.

• Execute quality and laboratory improvement initiatives and other projects within the organization.

• Performs equipment preventive maintenance and calibration.

• Performs review of laboratory documents such as orphan data check and equipment logs.

• Performs other duties as assigned by the direct manager.

Qualifications

Required

• Bachelor’s degree in Science/Life Science, Pharmaceutical Science, Engineering, or proven relevant experience.

• 2 to 3 years of applied professional work experience in the quality laboratory.

Preferred

• Leadership skills and ability to influence and collaborate with stakeholders at various levels.

• Customer focus with strong business acumen and continuous improvement mindset.

• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.

• Strong communication and interpersonal skills.

• Ability to work effectively in a team-based environment.

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Chemical Analysis, Collaborative Development, Data Analysis, GMP Compliance, Improvement Projects, Inspection Readiness, Karl Fischer Titrations, Laboratory Instrumentation, Laboratory Maintenance, Laboratory Safety, Laboratory Techniques, Microbiology Research, New Product Development, New Product Introduction (NPI), New Product Introduction Process, Quality Control Management, Teamwork, Technical Transfer, Technical Writing {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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, 2nd - Evening, 3rd - Night

Valid Driving License:

No

Hazardous Material(s):

Chemical Substances

Job Posting End Date:

09/30/2026

*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.