Lab Quality Assurance and Standards Lead

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.

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