Specialist, Quality Assurance at Merck & Co. De Soto County, LA

Specialist, Quality Assurance

De Soto County, LA.

The Quality Assurance Specialist role is responsible for providing guidance and support to implement, execute, and oversee compliance and quality-related processes in accordance with applicable GMP requirements and our company's Animal Health Quality Systems. The position will assist engineering, material management, supplier quality management, and warehouse areas, and will provide overall support with quality audit (internal and external).

• Knowledge and experience in assessing quality impact and GMP requirements applicable to qualification and validation of highly complex engineering and IT projects related to pharmaceutical product Manufacturing and Quality Control.
• Work experience in supporting engineering and maintenance-related processes in a pharmaceutical industry environment, such as GMP documentation review, deviation investigation, change control management, review and approval of commissioning and qualification documents.
• Understanding of supplier quality management systems and experience in, implementation and execution of the business processes to improve and prevent issues related to quality and compliance of purchased materials and contracted GMP services.

A successful candidate would need overall knowledge in a range of GMP regulations and guidelines, including GMP regulations such as USDA 9 CFR, FDA 21 CFR, Eudra Lex, ISO 9001 / ISO 15378, ICH Q7, and ICH Q9. This suggests the candidate will evaluate supplier compliance with these standards, ensuring the quality and safety of goods and services used in the pharmaceutical industry or other regulated product.

• Collaboration with stakeholders and a focus on problem solving, considering a balanced risk approach, and creating value for the business.
• Effective oral and written communication, and ability to negotiate, lead, and influence others.
• Time management, discipline, and organizational skills to deliver according to project timelines and aligned with company KPIs.
• Autonomy to provide guidance and make timely decisions related to identified quality and compliance issues.
• Teamwork, innovation, and ownership.

• Performs 3rd party (material supplier, service providers and contracted manufacturer) audits, timely write audit reports, work with suppliers to remediate audit observations, prepare and review supplier quality agreements and other documents supporting the External Network Quality Systems.
• Ensures appropriate CAPAs are assigned and properly completed by the 3rd party, addressing observations from the audit.
• Develops and executes supplier quality management improvement activities by assessing compliance with company requirements, developing methods and documents detailing processes for supplier oversight and quality improvement, providing training to other areas involved within the company, and ensuring conformance with requirements.
• Coordinates the execution of containment, root cause analysis, and effectiveness reviews for identified quality issues at suppliers and materials and services provided by third parties. Receive notification and timely elevate any issues related to materials and services provided by 3rd parties based on compliance, regulatory, and business risk to the appropriate management level within the organization.
• Builds and maintains strong relationships and communication plans with 3rd parties and internal stakeholders.
• Interacts with internal auditors and stakeholders, and supplier counterparts to resolve moderate to complex, systemic quality issues.
• Oversees materials management activities and supplier management programs and is a primary point of escalation for any Warehouse (receipt, storage, and destruction of purchased materials) and Procurement-related issue impacting purchased materials. Support with deviations, change controls and risk assessment documents related to materials management and warehouse operations.
• Provides support to engineering and maintenance-related processes impacting manufacturing and quality control operations to ensure compliance with regulatory and our company's Animal Health requirements.
• Reviews and approves engineering and maintenance-related documentation, such as SOPs, commissioning, and qualification documents for equipment, utilities, and automated/computerized systems; supports deviation investigation and definition of CAPAs and oversees the change control management process for the introduction and change of existing equipment, utilities, and systems.
• Utilizes data to define and recommend new or improved quality processes to assure product quality and resolve processing, inspection, and release problems.
• Serves as a backup for release of incoming raw materials and regulated packaging components.
• Contributes to the site inspection readiness plan by conducting Quality internal audits and facility documents audits, writes up…