Job Description:
We are seeking a highly skilled passionate and motivated scientist to join our Quality Control (QC) Operations and Metrology team to support day-to-day operations of the QC Laboratory. This role will support equipment qualification/calibrations manage vendors and assist with building out further organizational tools for the QC Laboratory. The position will be part of a technical operations team that aims to advance preclinical gene editing candidates into the clinic and works closely with IT Operations and internal/external quality control groups.
Key Responsibilities:
- Support the Quality Control Team/Lab and ensure that all state-of-the-art equipment is qualified calibrated and functioning to the expectations of the lab.
- Manage working relationships with various third-party equipment vendors. Schedule future calibrations and preventative maintenance for equipment within the QC Lab.
- Identify key consumables and supplies within QC Lab and maintain stock as needed.
- Maintain/organize all documentation generated for equipment/samples.
- Summarize results in presentations and technical reports.
- Track and trend temperature data for all controlled temperature storage units.
- Author and review equipment qualification reports protocols and other quality system documentation.
- Other duties as assigned.
Leadership Responsibilities:
- Supports and monitors the performance of the team of employees
- May participate in new hire interviews
- Supports the on-boarding process of new employees
- Disseminate administrative communications
- Demonstrate and promote the companys vision
- Ensure adherence to highest quality and efficiency standards in laboratory operations
- Ensure coverage and performance for all shifts and work duties
- Performs administrative tasks for team member growth and development
- Adeptly balance technical lab work with leadership responsibilities
- Foster morale and teamwork
Qualifications :
Minimum Required Qualifications:
- B.S. in Chemistry Biology or related field with 4-6 years of relevant experience.
- Proficiency with Good Documentation Practices in a cGMP-regulated environment.
- Demonstrated experience in equipment calibration and qualification activities (IQ/OQ/PQ) and laboratory inventory management
- Hands-on experience with instrumentation including PCR ELLA Fragment Analyzer lab freezers and refrigerators biosafety cabinets incubators cell counters and pipettes.
- Experience with LIMS or other data management systems and GxP Computer systems.
- Experience authoring reviewing and approving documents in Electronic Document Management Systems.
- Proven ability to manage multiple priorities and work independently.
- Thorough attention to detail with the ability to critically analyze ideas data and reports.
- Strong communication skills and customer-centric approach when coordinating with scientists vendors and service providers.
- Proactive mindset with the ability to take initiative solve problems and drive tasks to completion.
Preferred Qualifications:
- Background in quality assurance.
- Laboratory supervisor experience.
- Knowledge and understanding of ICH guidelines and FDA/EMA regulations.
- Knowledge of operational excellence and process improvement tools and methodologies including Lean and Six Sigma.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Additional Information :
Position is Full Time Monday-Friday 8am-5 pm. Candidates currently living within a commutable distance of Boston MA are encouraged to apply
Excellent full-time benefits include:
- Comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
- Compensation: $45.00-$48.00 per hour based on education and experience
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Job Description:We are seeking a highly skilled passionate and motivated scientist to join our Quality Control (QC) Operations and Metrology team to support day-to-day operations of the QC Laboratory. This role will support equipment qualification/calibrations manage vendors and assist with building...
Job Description:
We are seeking a highly skilled passionate and motivated scientist to join our Quality Control (QC) Operations and Metrology team to support day-to-day operations of the QC Laboratory. This role will support equipment qualification/calibrations manage vendors and assist with building out further organizational tools for the QC Laboratory. The position will be part of a technical operations team that aims to advance preclinical gene editing candidates into the clinic and works closely with IT Operations and internal/external quality control groups.
Key Responsibilities:
- Support the Quality Control Team/Lab and ensure that all state-of-the-art equipment is qualified calibrated and functioning to the expectations of the lab.
- Manage working relationships with various third-party equipment vendors. Schedule future calibrations and preventative maintenance for equipment within the QC Lab.
- Identify key consumables and supplies within QC Lab and maintain stock as needed.
- Maintain/organize all documentation generated for equipment/samples.
- Summarize results in presentations and technical reports.
- Track and trend temperature data for all controlled temperature storage units.
- Author and review equipment qualification reports protocols and other quality system documentation.
- Other duties as assigned.
Leadership Responsibilities:
- Supports and monitors the performance of the team of employees
- May participate in new hire interviews
- Supports the on-boarding process of new employees
- Disseminate administrative communications
- Demonstrate and promote the companys vision
- Ensure adherence to highest quality and efficiency standards in laboratory operations
- Ensure coverage and performance for all shifts and work duties
- Performs administrative tasks for team member growth and development
- Adeptly balance technical lab work with leadership responsibilities
- Foster morale and teamwork
Qualifications :
Minimum Required Qualifications:
- B.S. in Chemistry Biology or related field with 4-6 years of relevant experience.
- Proficiency with Good Documentation Practices in a cGMP-regulated environment.
- Demonstrated experience in equipment calibration and qualification activities (IQ/OQ/PQ) and laboratory inventory management
- Hands-on experience with instrumentation including PCR ELLA Fragment Analyzer lab freezers and refrigerators biosafety cabinets incubators cell counters and pipettes.
- Experience with LIMS or other data management systems and GxP Computer systems.
- Experience authoring reviewing and approving documents in Electronic Document Management Systems.
- Proven ability to manage multiple priorities and work independently.
- Thorough attention to detail with the ability to critically analyze ideas data and reports.
- Strong communication skills and customer-centric approach when coordinating with scientists vendors and service providers.
- Proactive mindset with the ability to take initiative solve problems and drive tasks to completion.
Preferred Qualifications:
- Background in quality assurance.
- Laboratory supervisor experience.
- Knowledge and understanding of ICH guidelines and FDA/EMA regulations.
- Knowledge of operational excellence and process improvement tools and methodologies including Lean and Six Sigma.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Additional Information :
Position is Full Time Monday-Friday 8am-5 pm. Candidates currently living within a commutable distance of Boston MA are encouraged to apply
Excellent full-time benefits include:
- Comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
- Compensation: $45.00-$48.00 per hour based on education and experience
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
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