Quality Assurance Associate II

Lab Quality Assurance and Standards Lead
This role will sit within the I & I TA and will be responsible for reviewing and enforcing lab safety and data quality in research practice and documentation and ensure compliance with ***'s GRP and research ethics standards.
1. Electronic Lab Notebooks (ELNs) - *** uses Benchling
a. Act as the TA representative at the global Digital Lab Notebook forum; attend monthly meetings and bring back any relevant updates to the LT and the TA.
b. Request account creation and access to ELN for new hires
c. Train new hires on the functionality and use of ELN for research documentation
d. Help troubleshoot ELN related issues either directly or by interfacing with the local ELN representative.
e. Notebook audits -
i. Spot check ELN entries on an ongoing basis to make sure they are compliant with ***'s Global Research Policy and research ethics standards.
ii. Coordinate with the Lab heads and senior researchers and set up quarterly notebook reviews within the TA.
iii. Working with the lab heads and senior researchers, conduct an annual ELN audit for the TA; generate a report of the results and communicate the outcomes to individuals as well as to the LT.
iv. Act as Lab Notebook Audit lead
f. Support the team with training on lab tools e.g. Biosource
g. Enable teams to overcome supply challenges for Client reagents
2. Specific Pharmacology reports (SPRs)
a. Lead project teams through the SPR process at ***
b. Act as an expert user of Veeva Vault and train scientists for report writing
c. Rigorously evaluate internal study reports and manuscripts for data consistency between the report and the cited ELN entries to support regulatory submissions.
d. Coordinate with the biostatistics representative to verify data consistency in the statistical analysis (if any).
e. Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements.
3. Support with the audit and maintenance of equipment, instruments, and other laboratory systems to ensure compliance with corporate policies and regulatory requirements.
4. Record, track, and notify supervisor/ LT of potential quality issues.
5. Health and Safety audits and corresponding corrective actions -
a. Waste Accumulation Area weekly inspection
b. Labels on all containers
c. Flammable/acid/base cabinet volume checks
6. Lab spot checks for expired reagents/materials
7. Assist with any additional job responsibilities or tasks based on business or departmental needs, as assigned.

Basic Qualifications
:
• Bachelor's Degree plus minimum 5 years of immunology research experience in an academic or biopharmaceutical setting OR Master's Degree plus minimum 2 years of immunology research experience in an academic or biopharmaceutical setting OR PhD plus minimum 2 years of immunology research experience in a biopharmaceutical setting.
• Experience working to GLP standards
• Extensive experience writing research reports for IND (Investigational new drug) filings
• Ability to work independently or with minimal supervision and effectively within timelines and collaborate in a highly matrixed global environment.
• Possesses strong communication skills, an exceptional work ethic and a willingness to spend time mentoring others.
Preferred Qualifications:
• Relevant immunology research experience in an academic or biopharmaceutical setting.