The University of Texas MD Anderson Cancer Center
QA Associate I/II
The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189
Job Title: QA Associate I/II
Job Number:
35522
Location:
San Diego,CA
Job Description
$70-80K
Quality Assurance Associate I/II
We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving companywide GLP/GCP/GMP controlled documentation, training, and facility support systems.
Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports
Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system
Coordinate / track / archive: controlled records (i.e., batch / test records, logbooks, validation documents, labels, reports, forms, etc) for change controls, deviations, CAPAs, audits, training, equipment calibration and preventative maintenance
Write and/or review policies, standards, procedures and work instructions to document Quality documentation processes and practices
Support supplier and material management, including ordering, incoming receipt, record keeping etc.
Inventory database management including accurate and timely updating of lot numbers and quantities
Collaborate on development / improvement and implementation of material, facility and quality management systems
Other required duties as may be assigned
Required Skills
Bachelor’s Degree and 2+ years of experience in a cGMP environment
Knowledge of standard processes involved in document control and experience in an FDA regulated environment
Experience in Aseptic Processing a plus
Precise attention to detail
Excellent record keeping skills
Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
Familiar with Quality Systems and records management in a cGMP environment.
Strong communication and problem-solving skills
Results oriented with dedication to compliance and customer service
Strong initiative and follow-through
Comfortable working in a fast paced and dynamic environment.
#J-18808-Ljbffr
Job Number:
35522
Location:
San Diego,CA
Job Description
$70-80K
Quality Assurance Associate I/II
We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving companywide GLP/GCP/GMP controlled documentation, training, and facility support systems.
Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports
Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system
Coordinate / track / archive: controlled records (i.e., batch / test records, logbooks, validation documents, labels, reports, forms, etc) for change controls, deviations, CAPAs, audits, training, equipment calibration and preventative maintenance
Write and/or review policies, standards, procedures and work instructions to document Quality documentation processes and practices
Support supplier and material management, including ordering, incoming receipt, record keeping etc.
Inventory database management including accurate and timely updating of lot numbers and quantities
Collaborate on development / improvement and implementation of material, facility and quality management systems
Other required duties as may be assigned
Required Skills
Bachelor’s Degree and 2+ years of experience in a cGMP environment
Knowledge of standard processes involved in document control and experience in an FDA regulated environment
Experience in Aseptic Processing a plus
Precise attention to detail
Excellent record keeping skills
Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
Familiar with Quality Systems and records management in a cGMP environment.
Strong communication and problem-solving skills
Results oriented with dedication to compliance and customer service
Strong initiative and follow-through
Comfortable working in a fast paced and dynamic environment.
#J-18808-Ljbffr