Quality Assurance Project Specialist
|Reference # :||18-00175||Title :||Quality Assurance Project Specialist|
|Location :||Abbott Park, IL|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||03/05/2018 / 08/10/2018|
Responsible for implementing and maintaining the effectiveness of the quality system. Design Control:
Documentation & Change Control: Understands and assesses the impact of changes on validation and manufacturability of a product. Analyzes data and draws conclusions. Assesses the impact of changes on product stability and dating. Able to identify critical parameters which define optimal reagents, primaries, panels, and references to assure consistent product performance across lots.
Quality System: Understands, implements, and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site level policies and procedures. Technical: Reviews and analyzes data, draws effective conclusions. Understands experimental design. Applies statistical tools, data analysis methods, knowledge of clinical applications, and technical writing skills to address failure analysis, spec. setting, and product development/improvement. Understands the consequences of product issues on product performance, customer acceptance, customer risk, compliance, and manufacturability.
Quality: Understands and meets current quality requirements to promote conformance to customer, regulatory and divisional
Corrective & Preventative Action: Identifies issues and guides teams to understand the root cause and resolution.
Has an understanding of diagnostic products, processes and technologies.
Able to support multiple products and projects.
Utilizes statistical tools to analyze data.
Understands multiple technologies and instrument platforms. Knows both qualitative and quantitative products.
Understands quality control procedures and manufacturing processes for final product.
Has an in-depth understanding of, and can assess justifications on change documents.
Must be able to identify issues, assess risk, make recommendations, and elevate issues as required.
Has knowledge of clinical applications for products for which they are responsible.
Understands intended use and off-label uses of products.
Responsible for implementing and maintaining the effectiveness of the quality system.,Participates as a new product team member and is able to identify and elevate critical issues.
Trains others and troubleshoots problems, may lead others in project teams.
Provides input, prepares and aligns departmental goals with business goals.
Participates with team and assures favorable outcome. Participates in cross functional teams.
Judges whether technical design of experiments are sufficient to answer the question being asked.
Identifies root cause through use of problem solving skills.
Functional application of statistical tools.
Applies problem solving skills to wide variety of problems: manufacturing process, failure investigation, product specifications and product design.
Makes Decisions: Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives. Utilizes good judgment and makes timely decisions which consider the facts and data at hand, champions specific projects, knows when to escalate to management. Surfaces Problems/Presents Ideas for Resolution: Highlights issues and presents possible resolutions.
Identifies and reports problems in a timely and accurate basis and seeks additional information when problem is beyond area of personal expertise. Takes personal responsibility to resolve issues.
Builds Relationships: Follows through on promises and commitments and maintains confidences.
Manages Personal Effectiveness: Controls emotional reactions, copes with stress, is open to others' ideas, demonstrates an understanding and appreciation of differences in others, treats others as individuals with unique skills, interests and values, seeks to understand the goals and needs of others. Promotes productivity and morale by treating others with respect and dignity.
Listens to different points of view, taking ownership and responsibility for own actions.
Confronts Issues: Raises issues that block the achievement of individual and team performance, voices opinions and concerns without waiting to be asked, communicates through areas of difference as well as areas of common issues, i.e.,can talk about both sides of an issue.
Resolves Conflicts: Directly confronts rather than avoids conflicts, depersonalizes conflict situations by focusing on issues rather than personalities and actively searches for win-win solutions.
Supports the work group: Takes the initiative to ensure that the work required of the group is accomplished, works with other members of the department to ensure smooth, effective and efficient operation, willingly helps peers by covering for meetings and other events.
Participates as a Team member: Contributes to the creation of the team's mission, objectives and strategies, accepts team decisions, works toward their implementation and displays sensitivity to group dynamics. Provides accurate and complete information.
Minimum Education & Experience
Bachelors Degree,preferable in the life or physical sciences or closely related field or sufficient related and transferable experience 5 years of experience in a quality or technical area; or clinical laboratory; Knowledge of regulations and standards affecting IVDs and Biologics is preferred.
Job Status: Contract/Temporary