Quality Associate, QC (Microbiology)

Grifols - Clayton, NC

Full-time

Clayton, NC

Chemical Manufacturing

About the position

The Quality Associate, QC plays a crucial role in supporting the operations of a Quality Control laboratory within Grifols, a global healthcare company dedicated to improving health and well-being since 1909. This position involves providing routine technical support for various tasks, including documentation, training, compliance, and test review. The Quality Associate is expected to coordinate work assignments and may also be responsible for training a small group of employees. The role requires effective communication at all levels of the organization to support departmental objectives and management decisions, while adhering to cGMP and safety practices. In addition to the primary responsibilities, the Quality Associate will apply their expertise in testing to develop, validate, and troubleshoot analytical methods. They will serve as a Subject Matter Expert (SME) for laboratory assays and act as a resource for laboratory staff. The role also includes performing investigations, writing reports, and authoring Standard Operating Procedures (SOPs) and other laboratory documents. Collaboration with production, Quality Assurance, and Compliance on projects, incident investigations, and annual product reviews is essential. The Quality Associate will evaluate data and perform statistical analysis for various projects, and may serve as a system administrator and SME for various laboratory information systems and applications as required.

Responsibilities

• Collects, reviews, and may analyze data.
• Makes decisions independently, but within a well-defined area.
• Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.
• May coordinate work activities or train employees.
• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
• Demonstrates high levels of value and integrity.
• Follows cGMP and department safety practices.
• Applies expertise in testing to develop, validate and troubleshoot analytical methods.
• Serves as SME for laboratory assays and acts as a resource for laboratory staff.
• Performs investigations and writes reports.
• Authors SOPs and other laboratory documents.
• Collaborates with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews.
• Evaluates data and performs statistical analysis for various projects.
• Serves as system administrator and SME for various laboratory information systems and applications as required.

Requirements

• BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 2 yrs of relevant experience or an equivalent combination of education and experience.
• Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.