Pyramid Consulting
Lab Quality Assurance and Standards Lead
Pyramid Consulting, Boston, Massachusetts, us, 02298
Immediate need for a talented
Lab Quality Assurance and Standards Lead.
This is a
12+months contract
opportunity with long-term potential and is located in
Cambridge, MA (Onsite).
Please review the job description below and contact me ASAP if you are interested.
Job ID: 25-79846
Pay Range: $45 - $49/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
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 any 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. e. Notebook audits - Spot check ELN entries on an ongoing basis to make sure they are compliant with Client's Global Research Policy and research ethics standards. Coordinate with the Lab heads and senior researchers and set up quarterly notebook reviews within the TA. 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. Act as Lab Notebook Audit lead Support the team with training on lab tools e.g. Biosource Enable teams to overcome supply challenges for novel reagents 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 the cited ELN entries to support regulatory submissions. Coordinate with the biostatistics representative to verify data consistency in the statistical analysis (if any). Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements. Support with the audit and maintenance of equipment, instruments, and other laboratory systems to ensure compliance with corporate policies and regulatory requirements. Record, track, and notify supervisor/ LT of potential quality issues. Health and Safety audits and corresponding corrective actions - Waste Accumulation Area weekly inspection Labels on all containers Flammable/acid/base cabinet volume checks Lab spot checks for expired reagents/materials Assist with any additional job responsibilities or tasks based on business or departmental needs, as assigned. Key Requirements and Technology Experience:
Key Skills; Writing, IND(Investigative brochure), Auditing, ELN/Labnotebook 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. Relevant immunology research experience in an academic or biopharmaceutical setting.
Our client is a leading
pharmaceuticals Industry
and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
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Lab Quality Assurance and Standards Lead.
This is a
12+months contract
opportunity with long-term potential and is located in
Cambridge, MA (Onsite).
Please review the job description below and contact me ASAP if you are interested.
Job ID: 25-79846
Pay Range: $45 - $49/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
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 any 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. e. Notebook audits - Spot check ELN entries on an ongoing basis to make sure they are compliant with Client's Global Research Policy and research ethics standards. Coordinate with the Lab heads and senior researchers and set up quarterly notebook reviews within the TA. 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. Act as Lab Notebook Audit lead Support the team with training on lab tools e.g. Biosource Enable teams to overcome supply challenges for novel reagents 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 the cited ELN entries to support regulatory submissions. Coordinate with the biostatistics representative to verify data consistency in the statistical analysis (if any). Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements. Support with the audit and maintenance of equipment, instruments, and other laboratory systems to ensure compliance with corporate policies and regulatory requirements. Record, track, and notify supervisor/ LT of potential quality issues. Health and Safety audits and corresponding corrective actions - Waste Accumulation Area weekly inspection Labels on all containers Flammable/acid/base cabinet volume checks Lab spot checks for expired reagents/materials Assist with any additional job responsibilities or tasks based on business or departmental needs, as assigned. Key Requirements and Technology Experience:
Key Skills; Writing, IND(Investigative brochure), Auditing, ELN/Labnotebook 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. Relevant immunology research experience in an academic or biopharmaceutical setting.
Our client is a leading
pharmaceuticals Industry
and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
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