Quality Specialist/Compliance Management

Merck • Wilson, NC, US • 3d ago

Responsibilities

Complaint Management:

Supports the Complaint Management Topic ensuring all product quality complaints (PQC) are investigated within the specified timeframes and Corrective and Preventive Actions are identified when required.
Assess whether reporting to Health Authority is required.
Performs trending to identify any specific or recurring problems.
Approves low and medium risks complaint investigations.
Manage incoming mailbox (complaints)
Destruction of aging complaint samples.

Education Requirements:

Bachelor’s degree preferred. Candidates with Associates degree considered pending relative experience.

Required Skills:

Possesses 3-5 years of basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
Ability to perform routine assignments and develops competence by performing structured work assignments.
Ability to use existing procedures to solve routine and standard problems.
Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues.
Promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.
Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.
Readily accepts performance feedback and incorporates this feedback into future performance.
Learns to use new problem solving tools to solve issues.
Ability to interpret Merck Quality Policies, Procedures and Guidelines for daily application.
Developing technical writing capabilities and is able to compile straightforward investigations and procedures.

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