What are the responsibilities and job description for the QA Specialist position at The Community Blood Center?
JOB REQUIREMENTS: Do you like working behind-the-scenes, but want a job
that impacts people in your community? Then consider becoming a Quality
Assurance Specialist at The Community Blood Center. By joining our team,
you\'ll play a critical role in this life-saving mission. JOB SUMMARY:
The Quality Assurance Specialist is a full-time position responsible for
ensuring compliance with regulatory, accreditation, certification, CBC,
and customer requirements. This role supports the implementation of
effective manufacturing processes and system controls to promote
continuous product safety and quality. The specialist ensures current
Good Manufacturing Practices (cGMPs) are adhered to and integrated
Across All Organizational Systems. ESSENTIAL DUTIES AND RESPONSIBILITIES
(other duties may be assigned): 1. Maintains and recommends improvements
to The Community Blood Center\'s Quality Plan. 2. Reviews and implements
SOP\'s and training documents related to Quality Assurance processes and
systems in order to ensure regulatory compliance. 3. Reviews and
critiques SOP\'s and training documents submitted from department
management for adherence to current FDA, AABB, and other regulatory
guidelines. 4. Provides training and education regarding quality, cGMP,
and safety for the organization. 5. 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. 6. Assists users of quality management software in analysis
and reporting of data. 7. Participates in quality improvement and
corrective action teams within and across operational areas. 8. Reviews
data from quality management software and other sources to identify
trends. Communicates trends to management. 9. Reviews equipment and
process validation documentation. 10. 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. 11.
Participates in the tracking, monitoring, and reporting of quality
indicators. Performs trend analysis to monitor process and facility
performance. 12. Develops audit plans, conducts quality audits, prepares
audit reports and communicates findings, including compliance risk. 13.
Assists with external inspections as needed. 14. Assures quality service
to all customers. 15. Complies with all policies and procedures outlined
in the CBC Employee Handbook, Center SOP\'s, and/or directives.
Maintains current level of job-related skills by attending in-services,
training sessions, and reading publications. 16. Performs all other
duties, at the discretion of management, as assigned. \*\*\*\*\* OTHER
EXPERIENCE AND QUALIFICATIONS: JOB QUALIFICATION REQUIREMENTS:
Bachelor\'s degree preferred. Experience in medical technology or a
clinical allied health field is preferred. 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 Employee may
occasionally be required to lift objects or materials weighing up to 25
pounds. \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
https://www.communityblood.org/current-openings/qa-specialist/
that impacts people in your community? Then consider becoming a Quality
Assurance Specialist at The Community Blood Center. By joining our team,
you\'ll play a critical role in this life-saving mission. JOB SUMMARY:
The Quality Assurance Specialist is a full-time position responsible for
ensuring compliance with regulatory, accreditation, certification, CBC,
and customer requirements. This role supports the implementation of
effective manufacturing processes and system controls to promote
continuous product safety and quality. The specialist ensures current
Good Manufacturing Practices (cGMPs) are adhered to and integrated
Across All Organizational Systems. ESSENTIAL DUTIES AND RESPONSIBILITIES
(other duties may be assigned): 1. Maintains and recommends improvements
to The Community Blood Center\'s Quality Plan. 2. Reviews and implements
SOP\'s and training documents related to Quality Assurance processes and
systems in order to ensure regulatory compliance. 3. Reviews and
critiques SOP\'s and training documents submitted from department
management for adherence to current FDA, AABB, and other regulatory
guidelines. 4. Provides training and education regarding quality, cGMP,
and safety for the organization. 5. 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. 6. Assists users of quality management software in analysis
and reporting of data. 7. Participates in quality improvement and
corrective action teams within and across operational areas. 8. Reviews
data from quality management software and other sources to identify
trends. Communicates trends to management. 9. Reviews equipment and
process validation documentation. 10. 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. 11.
Participates in the tracking, monitoring, and reporting of quality
indicators. Performs trend analysis to monitor process and facility
performance. 12. Develops audit plans, conducts quality audits, prepares
audit reports and communicates findings, including compliance risk. 13.
Assists with external inspections as needed. 14. Assures quality service
to all customers. 15. Complies with all policies and procedures outlined
in the CBC Employee Handbook, Center SOP\'s, and/or directives.
Maintains current level of job-related skills by attending in-services,
training sessions, and reading publications. 16. Performs all other
duties, at the discretion of management, as assigned. \*\*\*\*\* OTHER
EXPERIENCE AND QUALIFICATIONS: JOB QUALIFICATION REQUIREMENTS:
Bachelor\'s degree preferred. Experience in medical technology or a
clinical allied health field is preferred. 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 Employee may
occasionally be required to lift objects or materials weighing up to 25
pounds. \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
https://www.communityblood.org/current-openings/qa-specialist/
