Associate Specialist, Quality Lab
Job Description
Job Description
The position of Associate Specialist, (Quality Lab) in Pharm / Component Lab will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.
Associate Specialist (Chemist)
In this role, you will be responsible for all or subset of the key responsibilities below:
- Perform analytical testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances/ products according to approved procedures.
- Participate in analytical/ microbiological method transfer/ validation/ verification, new product introduction and equipment qualification.
- Assist in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.
- Provide inputs 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 special projects.
- Perform equipment preventive maintenance and calibration.
- Perform review of laboratory documents such as orphan data check and equipment logs.
What are we looking for?
Qualifications & Experience
- Bachelor’s degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
- 1 - 3 years of applied professional work experience in the Quality Laboratory.
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, Analytical Problem Solving, Analytical Testing, Bioburden Testing, Chemical Analysis, Data Analysis, Environmental Monitoring, GMP Compliance, Inspection Readiness, Karl Fischer Titrations, Laboratory Analysis, Laboratory Instrumentation, Laboratory Maintenance, Laboratory Techniques, Life Science, Microbiology Research, New Product Introduction (NPI), New Product Introduction Process, Stakeholder Engagement, Strategic Thinking, Teamwork, Technical Transfer {+ 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:
Temporary (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/22/2026*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.