Integrated Resources
Job Title:
Quality Assurance Associate II Location:
Cambridge, MA 02141 Duration:
12 Months+ (Possible Extension)
Pay range:
$48 - $51/hr. on W2
Manager Notes:
Auditing minimum notebook requirements, ELN to ensure notebook standards are being met. Will conduct bi-annual audits, spot check notebooks to ensure they meet qualifications for pharmacology reports. Assist with collaboration with licensing audit and notebook checks.
Must Have Skills:
Bachelor's degree and minimum of 5+ years of immunology research experience. Master's degree and minimum of 2+ years of immunology research experience. Research experience in a biopharmaceutical setting. ELN, Benchling or similar experience. Experience working to GLP standards. Extensive experience writing research reports for IND (Investigative Brochure) filings. Preferred:
Mix of hands-on lab experience and auditing experience. Lab background is preferred; in vivo and in vitro is a plus.
Job Description: 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 ensuring compliance with Client's GRP and research ethics standards.
1. Electronic Lab Notebooks (ELNs)
- Client uses Benchling:
Act as the TA representative at the global Digital Lab Notebook forum; attend monthly meetings and bring back relevant updates to the LT and the TA. Request account creation and access to ELN for new hires. Train new hires on the functionality and use of ELN for research documentation. Help troubleshoot ELN-related issues either directly or by interfacing with the local ELN representative. Notebook audits:
Spot check ELN entries on an ongoing basis to ensure compliance with Client's Global Research Policy and research ethics standards. Coordinate with Lab Heads and Senior Researchers to set up quarterly notebook reviews within the TA. Working with Lab Heads and Senior Researchers, conduct an annual ELN audit for the TA; generate a report of the results and communicate outcomes to individuals and the LT. Act as Lab Notebook Audit Lead.
Support the team with training on lab tools (e.g., Biosource). Enable teams to overcome supply challenges for Client reagents.
2. Specific Pharmacology Reports (SPRs):
Lead project teams through the SPR process at Client. Act as an expert user of Veeva Vault and train scientists for report writing. Rigorously evaluate internal study reports and manuscripts for data consistency between the report and cited ELN entries to support regulatory submissions. Coordinate with the Biostatistics Representative to verify data consistency in statistical analysis (if applicable). Coordinate with the Dossier Management Group and Biology Leads to ensure study report conforms with prescribed formatting requirements.
3. Equipment and System Audits:
Support the audit and maintenance of equipment, instruments, and other laboratory systems to ensure compliance with corporate policies and regulatory requirements.
4. Quality Issue Tracking:
Record, track, and notify supervisor/LT of potential quality issues.
5. Health and Safety Audits and Corrective Actions:
Waste Accumulation Area weekly inspection. Ensure labels are on all containers. Conduct flammable/acid/base cabinet volume checks.
6. Lab Spot Checks:
Check for expired reagents/materials.
7. Additional Duties:
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, 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. Ability to 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.
Quality Assurance Associate II Location:
Cambridge, MA 02141 Duration:
12 Months+ (Possible Extension)
Pay range:
$48 - $51/hr. on W2
Manager Notes:
Auditing minimum notebook requirements, ELN to ensure notebook standards are being met. Will conduct bi-annual audits, spot check notebooks to ensure they meet qualifications for pharmacology reports. Assist with collaboration with licensing audit and notebook checks.
Must Have Skills:
Bachelor's degree and minimum of 5+ years of immunology research experience. Master's degree and minimum of 2+ years of immunology research experience. Research experience in a biopharmaceutical setting. ELN, Benchling or similar experience. Experience working to GLP standards. Extensive experience writing research reports for IND (Investigative Brochure) filings. Preferred:
Mix of hands-on lab experience and auditing experience. Lab background is preferred; in vivo and in vitro is a plus.
Job Description: 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 ensuring compliance with Client's GRP and research ethics standards.
1. Electronic Lab Notebooks (ELNs)
- Client uses Benchling:
Act as the TA representative at the global Digital Lab Notebook forum; attend monthly meetings and bring back relevant updates to the LT and the TA. Request account creation and access to ELN for new hires. Train new hires on the functionality and use of ELN for research documentation. Help troubleshoot ELN-related issues either directly or by interfacing with the local ELN representative. Notebook audits:
Spot check ELN entries on an ongoing basis to ensure compliance with Client's Global Research Policy and research ethics standards. Coordinate with Lab Heads and Senior Researchers to set up quarterly notebook reviews within the TA. Working with Lab Heads and Senior Researchers, conduct an annual ELN audit for the TA; generate a report of the results and communicate outcomes to individuals and the LT. Act as Lab Notebook Audit Lead.
Support the team with training on lab tools (e.g., Biosource). Enable teams to overcome supply challenges for Client reagents.
2. Specific Pharmacology Reports (SPRs):
Lead project teams through the SPR process at Client. Act as an expert user of Veeva Vault and train scientists for report writing. Rigorously evaluate internal study reports and manuscripts for data consistency between the report and cited ELN entries to support regulatory submissions. Coordinate with the Biostatistics Representative to verify data consistency in statistical analysis (if applicable). Coordinate with the Dossier Management Group and Biology Leads to ensure study report conforms with prescribed formatting requirements.
3. Equipment and System Audits:
Support the audit and maintenance of equipment, instruments, and other laboratory systems to ensure compliance with corporate policies and regulatory requirements.
4. Quality Issue Tracking:
Record, track, and notify supervisor/LT of potential quality issues.
5. Health and Safety Audits and Corrective Actions:
Waste Accumulation Area weekly inspection. Ensure labels are on all containers. Conduct flammable/acid/base cabinet volume checks.
6. Lab Spot Checks:
Check for expired reagents/materials.
7. Additional Duties:
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, 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. Ability to 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.