Quality Associate II, III, QC

First Shift

Quality Associate II, QC

The Quality Associate, QC provides routine technical support for various tasks (i.e. documentation, training, compliance, test review, scheduling, etc.), assignments, projects, etc. for the QC Sterility laboratory. He/she will be responsible for coordinating work assignments or training a small shift or group of employees in the Sterility laboratory.

• Collects, reviews, and analyzes data.
• Makes decisions independently, but within a well-defined area.
• Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.
• Coordinates work activities and scheduling.
• Coordinates employee training.
• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
• Contributes cross-functionally within the departmental hierarchy.
• Demonstrates high levels of value and integrity.
• Follows cGMP and department safety practices.

In addition to the duties described above the Quality Associate QC may also perform the following duties:

Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects.

Serve as system administrator and SME for various laboratory information systems and applications as required.

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. Proficiency using SAP is strongly preferred. Detail oriented and great organizational and communication skills are a must. Excellent prioritization, multitasking and leadership skills are crucial. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Example:
If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate’s degree with 6 years of experience, or a master’s degree with 2 years of experience.

This position is a technical and testingsupport position within the QC Sterilitylaboratory. Prior experience with instrumentation, software and data entry systems used to performsterility testing and visual appearanceassays (for example,the closed canister filtration system, Sterility testing peristaltic pump, visual light stations, etc) is highly preferred. Hiring level will be dependent on experience level. A strong technical aptitude and experience with Microsoft Word, Excel and SAPas well as technical report writing, is strongly desired.

• Overseeing the performance of all instrumentation utilized within the QC Chemistry laboratory.
• Use instrument/assay knowledge to troubleshoot issues and to provide assistance to testing analysts
• Oversee the purchase, installation and qualification of new instruments
• Work with various instrument vendors to arrange service and overseeing vendor repairs and approval of service contracts
• Prepare analytical based reprots as needed
• May provide supprot to managing the standards and control program within the laboratory
• Overseeing the validation of new test methods (includes drafting protocols, execution and drafting final reports)

BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience

The ideal candidate should be a fully qualified professional who requires minimal supervision and makes independent decisions within designated assignments;
Demonstrates high levels of integrity and value as well as consistent application of technical knowledge and…