Quality Assurance Document Control
PECIFIC DUTIES, ACTIVITIES, AND
Responsibilities:
oReview and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
o Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
oMonitor schedule for production priorities.
oAttend scheduling meetings when needed.
oReview of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.
oConfirm proper randomization schedule utilization for correct patient treatment group assignment.
oPrimary liaison with client for batch release.
oCommunicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.
Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
oEnsure timely release of batch for protocol initiation date.
oRelease batch within Scheduling database.
oRelease batch within JDE inventory management system.
oRecord and track errors and not-right-first-time to maintain departmental metrics.
oArchive batch documents onto shared drive and within archive room.
oEnsure that responsibilities are completed efficiently while maintaining Quality.
oPromotes a positive working environment.
oCoach new QADC staff through day to day activities when needed.
oCommunicates SQDC counter measures and safety issues to Quality Management.
oEnsures QADC metrics are met or takes action to correct.
oComplies with EH&S and 5S requirements for QADC.
oOther tasks or projects as assigned.
POSITION REQUIREMENTS:
Supervises:
N/A Education or Equivalent:
BA/BS or High School Diploma with relevant industry experience.
Knowledge/Skills Requirements:
(List unique knowledge skills, or problem-solving requirements) o Attention to detail o Good organizational/time management skills o Exercises sound judgment and analytical in thought o Challenges status quo and initiates improvements o Ability to multi-task o Communication skills o Good math skills o Basic computer skills Recommended Skills Analytical Attention To Detail Clinical Trial Protocols Clinical Works Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
oReview and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
o Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
oMonitor schedule for production priorities.
oAttend scheduling meetings when needed.
oReview of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.
oConfirm proper randomization schedule utilization for correct patient treatment group assignment.
oPrimary liaison with client for batch release.
oCommunicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.
Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
oEnsure timely release of batch for protocol initiation date.
oRelease batch within Scheduling database.
oRelease batch within JDE inventory management system.
oRecord and track errors and not-right-first-time to maintain departmental metrics.
oArchive batch documents onto shared drive and within archive room.
oEnsure that responsibilities are completed efficiently while maintaining Quality.
oPromotes a positive working environment.
oCoach new QADC staff through day to day activities when needed.
oCommunicates SQDC counter measures and safety issues to Quality Management.
oEnsures QADC metrics are met or takes action to correct.
oComplies with EH&S and 5S requirements for QADC.
oOther tasks or projects as assigned.
POSITION REQUIREMENTS:
Supervises:
N/A Education or Equivalent:
BA/BS or High School Diploma with relevant industry experience.
Knowledge/Skills Requirements:
(List unique knowledge skills, or problem-solving requirements) o Attention to detail o Good organizational/time management skills o Exercises sound judgment and analytical in thought o Challenges status quo and initiates improvements o Ability to multi-task o Communication skills o Good math skills o Basic computer skills Recommended Skills Analytical Attention To Detail Clinical Trial Protocols Clinical Works Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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