QUALITY ASSURANCE ASSISTANT

General Position Summary

Supports the Quality Assurance team by reviewing quality records as well as analytical and physical evaluation of Sakura products to ensure the finished products meet the expectations.

Essential Job Functions

Assistant Activities

• Within established processes and procedures, reviews and approves Device History Records (DHR's) generated by Device and Packaging production operations.
• Reviews Quality Control testing and inspection data results.
• Responsible for the release of products for commercial distribution.
• Prioritizes workload to ensure timely and accurate review of DHR documents.
• Reconciles any potential non-compliance found during DHR review; requests corrections from initial sources as needed.
• Works in collaboration with Quality team and other departments to obtain, clarify and summarize necessary information, data to perform product approval.
• Assists with failure investigations conducted for Out of Specifications, nonconformance and CAPA.
• Adheres to and ensures the compliance of manufacturing and QC records and procedures as well as company policies, rules, procedures; and housekeeping standards.
• Administrates Sakura Safety Data Sheets; serves as a liaison between Quality and Chemistry to support operations in creating and updating SDSs.
• Responsible for initiating and submitting Document Change Orders for Sakura safety data sheets.
• Assist QA manager with the review of department standard operating procedures (SOPs), forms, templates and DHR checklists.
• Perform basic office tasks such as scanning, filling, and maintaining DHR archives.
• Performs all other duties as assigned by management.

Information Management & Reporting Activities

• Performs data analysis.
• Provides feedback by preparing charts, graphs, reports and other methods of communication as to how well the Quality System is working.

Other Activities

• Mathematical skills - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals.
• Ability to compute rate, rations and percent.
• Ability to read, understand and interpret work instructions and operating procedures.
• Problem solving skills/good interpersonal skills - Ability to interact positively with peers, department managers and above.
• Ability to work independent with minimal supervision - good decision-making skills.
• Ability to multi-task and prioritize workload.
• Attitude - Demonstrate and outward attitude of support for both company and the Quality organization.

Essential Job Requirements

Education

• High School diploma or general education degree (GED) required.
• Associates degree (A.A.) preferred

• To perform this job successfully, the individual must be able to perform each principle responsibly and satisfactorily. The requirements listed above are representative of the knowledge skill, and or ability required.

Experience & Minimum Qualifications

• Two or more years of administrative support experience.
• Ability to use a personal computer and have working knowledge of Microsoft Office software products, i.e. Word, Excel, Windows, Outlook & Project and PowerPoint.
• Ability to write reports, chart data and provide other technical documentation.
• Ability to use software for problem solving and analytical skills.
• Ability to meet project deadlines and work within budgetary constraints.
• Ability to effectively present information and respond to questions from management.
• Ability to apply common sense to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving product failure, analysis and remedial actions
• Ability to get along well with diverse personalities. Must be tactful and flexible.
• Ability to pay attention to detail. High level of concentration and attention to detail for extended periods of time required to perform DHR review and product approval.

Physical Requirements & Working Environment

• This position requires the employee to frequently sit. In addition, the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.

• Ability to verbally respond to customers in person or over the telephone.
• Must be able to occasionally lift and/or move up to 20 pounds.
• Ability to read and analyze hard written copy and information on a computer screen.
• Ability to communicate verbally and in writing to individuals and groups.
• Ability to communicate verbally in person and using a phone.
• Ability to listen for understanding and assist in problem solving.

"Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law."

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.