Job Description:

Position Overview:

The position of Specialist provides quality oversight on Supplier qualification & management and co-ordinates with central quality functions as needed. The role will ensure and maintain high standards of quality and compliance within our organization.

** Essential Functions and Responsibilities (includes, but are not limited to):** The ​Associate/Specialist (P1/2)​, Supplier Quality is responsible to:

• Acts as the subject matter expert for Supplier quality management engaging directly in internal and external quality/ regulatory audits and in the development and execution of any remediation actions that may be required.

• Establish Quality/Change agreements between company and suppliers, ensure content alignment through coordination with site SMEs, and manage the end-to-end approval workflow.

• Update site SOPs to reflect the changes needed to achieve compliance with Quality Manual/ GDL requirements.

• Manage and maintain Supplier related EDMS, where applicable.

• Supervise and oversee Third Party Contractors, involved in the supplier qualification process where applicable.

• Demonstrate the ability to independently solve problems that arise within job responsibilities and expectations. Able to organize information in a logical way and combine data and information from multiple sources in new ways to determine causes of issues.

• Apply appropriate knowledge of compliance requirements, HA and regulatory authority expectations and business intelligence to support development of and amendments to internal quality policies.

• Track and manage CAPA commitments from supplier to avoid any overdue.

• Drive collaboration and transformational culture change.

• COMET QM System Support​

• Review, approve as provide support as site SME for COMET QM system updates

• Qualifications & Experience

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

• 300/ P1 Specialist

• 1-3 years of relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA.

• Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.

• 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: Accountability, Accountability, Analytical Problem Solving, Aseptic Filling, Business Intelligence (BI), cGMP Compliance, Collaborative Development, Communication, Complaint Management, Decision Making, Deviation Management, Diagnosing Problems, GMP Compliance, Good Manufacturing Practices (GMP), Identifying Problems, Information Organization, Life Science, Pharmaceutical Manufacturing, Pharmaceutical Systems, Pharmacology, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS) {+ 5 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: Intern/Co-op (Fixed Term)

Relocation:VISA Sponsorship:Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:Valid Driving License:Hazardous Material(s):

Job Posting End Date:

03/5/2026

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.