Quality Specialist/Compliance Management jobs in United States
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Merck · 7 hours ago

Quality Specialist/Compliance Management

Merck is a leading company in the pharmaceutical industry, and they are seeking a Quality Specialist to support their Complaint Management Topic. The role involves investigating product quality complaints, managing complaint investigations, and ensuring compliance with health authority reporting requirements.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
Hiring Manager
Abby Lauman
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Responsibilities

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

Qualification

Quality Assurance knowledgePharmaceutical operations systemsProblem solving toolsTechnical writingPerformance feedback acceptanceTeam collaboration

Required

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

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase