Associate Specialist, Quality Assurance (WDA)

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

• Bachelors 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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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