Altasciences
SeniorQAAuditor,GLP
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“Senior QA Auditor, GLP at Altasciences. Skills: GLP auditing, Regulatory compliance, Process improvement. Carry out systematic examination of study activities. Determine study activities conducted according to protocol”
Industry & Context.
Process improvement recommendations
What They're Looking For.
Must Have
Bachelor degree or higher in scientific discipline, Two to three years related technical experience, Minimum two years auditing in GLP-regulated environment, Microsoft Office Suite
Nice to Have
Professional certification such as RQAP-GLP, ASQ-CQA certification, Other certification recommended
What You'll Do.
Carry out systematic examination of study activities
Determine study activities conducted according to protocol
Determine data recorded according to protocol
Determine data analyzed according to protocol
Determine data reported according to protocol
Report findings to Study Director
Report findings to Responsible Person
Report findings to Testing Facility Management
Build effective working relationships
Maintain effective working relationships
Mentor lower-level staff
Coach lower-level staff
Audit phases of nonclinical studies
Audit phases of laboratory studies
Issue audit statements
Audit Method Validations
Audit Non-Clinical GLP Studies
Perform process audits
Perform vendor qualifications
Perform equipment validation audits
Perform software validation audits
Act as lead auditor on studies
Act as lead auditor on projects
Maintain computerized files
Support project planning
Support project implementation
Provide risk-based compliance opinions
Provide risk-based compliance guidance
Write inspection reports
Issue inspection reports
Communicate inspection findings to internal clients
Evaluate inspection finding responses
Ensure SOPs are current
Ensure SOPs are practiced
Identify opportunities for process improvements
Communicate opportunities for process improvements
Participate in process improvement activities
Guide process improvement activities
Maintain documentation of QA records
Maintain documentation of study files
Notify management of quality trends
Notify management of compliance trends
Perform SOP QA review
Perform external test site qualifications
Perform analytical laboratory qualifications
Interpret FDA regulatory guidance
Interpret project regulatory guidance
Interpret quality issue regulatory guidance
Interpret QA data collection guidance
Interpret QA data trending guidance
Interpret QA data analysis guidance
Recommend modifications in procedures
Involve manager in process improvement
Involve manager in resolution
Interpret associated regulatory documents
Train on associated regulatory documents
Carry out self-development efforts
Assist with regulatory training of staff
How You'll Work.
Team & Collaboration
Working relationships throughout organization
Communication Scope
Written communication; Verbal communication; French communication; English communication
Process & Methodology
Project planning, Project implementation
Full Job Description
**Your New Company!** At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. **About The Role** The Senior QA Auditor, GLP is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff. **What You 'll Do Here** * Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance. * Audits all disciplines (examples of disciplines include Method Validations, Non- Clinical GLP Studies). * Performs process audits, vendor qualifications, equipment and software validation audits. * Acts as lead auditor
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