Quality Assurance II

Quality Assurance Specialist II

CooperSurgical, Inc

Los Angeles, California

Summary

Supports Quality Management Systems, including Complaint, Deviation, Nonconformance, and CAPA Management, donor chart review, tissue release, complaints, and other process improvements by performing the following duties.

You Will:

• Reviews sperm donor charts for completeness of all required testing and documents prior to release of tissue.
• Redacts and/or reviews egg donor SOR packets for completeness and/or accuracy.
• Reports and tracks errors discovered during the sperm donor chart or egg donor SOR packet review process.
• Reviews vial and egg device status change forms for completeness and signs.
• Initiates and updates Summary of Records reports as part of the tissue release process, which includes reviewing documents for completeness, creating addendums and tables, data entry, scanning, naming, saving, archiving reports, and the maintenance of reports folders.
• Scans and files applicable documents in sperm donor charts as applicable.
• Performs and assists with Deviation, Complaint, Nonconformance, and CAPA activities.
• Performs data entry and basic statistical analysis; creates graphs and reports for various quality activities.
• Assists with chart audits for reproductive tissue services.
• Supports and implements Process Improvement activities.
• In collaboration with appropriate staff, revises procedures; may format documents and forms using Word, Excel, and Acrobat.
• Provides coverage as necessary to complete documentation required for international orders.

You Have:

• Bachelor's Degree in Biological Science or a closely related area of study and minimum of two years of healthcare, clinical laboratory, or tissue banking experience and/or training required. Knowledge of FDA HCT/P regulations (21CFR1271) and quality certification preferred.
• Ability to speak and write English; communicate effectively and professionally with clients and external contacts;
• read and interpret documents, such as donor eligibility/suitability forms and procedure manuals; write reports and correspondence; respond to common inquiries or complaints from clients and regulatory agencies; and effectively respond to questions from coworkers and management.
• Computational skills required to support essential duties and responsibilities including the ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Experience with statistical applications preferred.
• Ability to analyze data, carry out instructions furnished in written or oral form, and solve problems involving several concrete variables in standardized situations. Demonstrates ability to plan, organize, and complete assignments logically and independently.
• Knowledge of Microsoft Office, SharePoint, Adobe Acrobat, and MasterControl.
• Demonstrates ability to produce accurate work, follow procedures, meet deadlines, and manage multiple priorities. Demonstrates good problem-solving skills. Ability to work independently with minimal supervision; excellent customer service skills; high level of interpersonal skills to interact with peers and management in both one-on-one and team settings. Strong attention to detail and ability to maintain confidentiality.