QUALITY ASSURANCE SPECIALIST
The Quality Assurance Specialist I perform functions necessary to:
- Ensure compliance with regulatory, accreditation, certification, CBC, and customer requirements.
- Assist the organization in the implementation of effective manufacturing process and system controls to ensure continuous product safety and quality.
- Ensure cGMPs are followed and integrated within all systems of the organization.
Primary Job Responsibilities:
- Develops, maintains and improves Community Blood Center’s Quality Plan.
- Develops, reviews and implements SOPs and training documents related to Quality Assurance processes and systems, in order to ensure regulatory compliance.
- Reviews and critiques SOPs and training documents submitted from department management for adherence to current FDA, AABB Standards, and other regulatory guidelines.
- Provides training and education in quality, cGMP, and safety for the organization.
- Manages the change control process for policies, processes and procedures, which may include the implementation of new/revised documents, and the archiving of old documents.
- Assists users of quality management software in analysis and reporting of data.
- Participates in quality improvement and corrective action teams within and across operational areas.
- Reviews data from quality management software and other sources to identify trends. Communicates trends to management.
- Reviews equipment and process validation documentation.
- Evaluates deviations and non-conformances reported via the deviation management system and other sources. Determines if immediate correction is appropriate or should be evaluated for corrective action. Escalates to management errors requiring further evaluation and/or submission of reports to FDA.
- Participates in the development, tracking, monitoring, and reporting of quality indicators. Performs trend analysis to monitor process and facility performance.
- Develops audit plans, conducts quality audits, prepares audit reports and communicates findings, including compliance risk.
- Assists with external inspections as needed.
- Assures quality service to all customers.
- Complies with all policies and procedures outlined in the CBC Employee Handbook, Center SOPs, and/or directives. Maintains current level of job-related skills by attending in-services, training sessions, and reading publications.
- Performs all other duties, at the discretion of management, as assigned.
1-3 years of experience in a blood center, biologics, pharmaceutical or medical industry manufacturing environment with base familiarity of quality assurance practices, training, and federal regulatory practices is preferred.
- Excellent organizational, oral, and written communication skills.
- Strong analytical and problem-solving skills
- Strong, flexible interpersonal skills
- Skilled in observation of operational tasks
- Skilled in documentation review with special emphasis on details
- Computer skills with emphasis on word processing and database software
Submit your resume to join our team: https://workforcenow.adp.com/jobs/apply/posting.html?client=combctr&jobId=236565&lang=en_US&source=CC3
The Community Blood Center
4406 W. Spencer St.
Appleton, WI 54914
Community Blood Center, Inc. is an Equal Opportunity Employer M/F/Disability/Veteran