Job Description

WHAT YOU WILL DO

 

Specialist, Quality Control (In-Process Control Lab)

The position of Specialist in Quality Laboratory will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Performs, review/ release, and/or schedule analytical testing 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.
• Performs review of laboratory documents such as orphan data check and equipment logs.
• Performs laboratory assessments of compendial updates and implement changes to analytical standards.
• 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.

• Maintains proper laboratory housekeeping, laboratory inventory and ensure inspection readiness.
• Facilitates training to laboratory personnel, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Provides guidance and support in resolving technical issues and challenges encountered during work.
• Participates/ leads in continuous improvement initiatives and other and other projects within the organization.
• Performs equipment preventive maintenance and calibration.
• Performs any other duties as assigned by the laboratory manager.

 

WHAT YOU SHOULD HAVE

Qualifications & Experience

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

• 4 to 6 years of applied professional work experience in the quality laboratory.
• Technical competency in analytical troubleshooting.

Personal Qualities

• Leadership skills and ability to influence/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, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Inspection Readiness, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, New Product Introduction (NPI), New Product Introduction Process, Quality Control Management, Quality Management, Quality Standards, Regulatory Responses, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Thinking, Teamwork, Technical Issues, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/8/2026

*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.