Artech LLCLexington (MA), 15 mi from Framingham
Bioanalytical Data Reviewer/ Quality Control
HYBRID ROLE
Lexington, MA.
Pay Rate Range is $25.34-$32.97 Per hour.
MUST HAVES:
Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology...
US Tech Solutions, Inc.Lexington (MA), 15 mi from Framingham
Must Haves:
Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology group
Familiarity with Bioanalytical sample and data analysis
Attention to detail and experience with raw data QC...
GTT, LLCNorwood (MA), 16 mi from Framingham
Quality Control Raw Materials Associate
Contract Duration 6+ months
Pay rate up to $0.69/hr - $38.54/hr
The Role:
Reporting to the Associate Director of Quality Control, our client is seeking a Quality Control Raw Materials Associate II based...
Booz Allen HamiltonLexington
Cloud Application Migration Project Manager. As an Application Migration Program Manager, you know how to take advantage of cloud. Experience with project management tools, including Jira, Trello, or Asana. Knowledge of project management methodologies, including Agile, Waterfall, and DevOps.
...
NCH Healthcare SystemWellesley
The coordinator supports the functions of Quality & Patient Safety with clinicians, providers, and IT staff to improve EMR documentation to support quality data reports, mandatory quality reporting and performance metrics. The RN Safety & Quality Coordinator for Women & Child Health is a professiona...
NCH Healthcare SystemWellesley
The RN Safety & Quality Coordinator Emergency Services & Sepsis is a professionally trained RN responsible for leading the efforts to advance patient safety culture and performance improvement throughout the Emergency Services and Sepsis management throughout the organization.
Certification in Healt...
NCH Healthcare SystemLexington
The RN Safety & Quality Coordinator Emergency Services & Sepsis is a professionally trained RN responsible for leading the efforts to advance patient safety culture and performance improvement throughout the Emergency Services and Sepsis management throughout the organization.
Certification in Healt...
Randstad Life Sciences USNorwood (MA), 16 mi from Framingham
Title: Quality Control Bioassay Associate I
Location: Norwood, MA
Pay: $25-32/hr
Contract: 6+ months
Multiple Shifts Available
Job Summary
The Bioassay QC Analyst 1 will be responsible for GMP release testing of products produced at the GMP...
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Principal Microbiologist, QC
Framingham | careers-replimune.icims.com |
Overview:
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories.
Working in collaboration with cross functional teams, the Principal Microbiologist, QC will be responsible for setting up and maintaining QC Microbiology programs. The Principal Microbiologist will be responsible for establishing procedures to support environmental monitoring and utilities testing (water, gas and air supplies).
The Principal Microbiologist will be responsible for overseeing the Contamination Control Strategy, Environmental Monitoring Risk Assessment, and studies regarding Microbiological Assays (Bioburden, Endotoxin, Sterility).
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities:
The responsibilities of the Principal Microbiologist, QC include, but are not limited, to the following:
• Setting up and maintaining of the QC Microbiology systems
needed to enable testing requirements in support of the facility.
• Establishing and overseeing the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Oversee the environmental monitoring program including aseptic fill finish (Grade A/B) monitoring. Play a leading role in any excursions and assessing the impact.
• Continually develop the environmental monitoring program in line with regulatory requirements and industry guidance. Develop robust procedures to monitor and proactively
identify any trends.
• Play a leading role in the development of the contamination control strategy.
• Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis and raw materials testing.
• Management/planning of water sampling and associated water testing
• Ensure completion of change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
• Author QC regulatory documentation and assist in regulatory audits/inspections, as needed.
• Troubleshooting of equipment and QC methods.
• Manage / perform assay qualification, as necessary.
• Manage Microbiology related technical studies performed with external companies and review of reports.
Qualifications:
Experience and skill requirements:
• Minimum 10 years GLP/GMP laboratory-based experience in a Microbiology testing capacity in a GMP-Regulated environment.
• Good analytical skills and technical experience is a must, preferentially with previous experience setting up a testing laboratory and/or supporting a manufacturing facility.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills
• Experience in PAI, agency regulated Audits preferred
Location:
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories.
Working in collaboration with cross functional teams, the Principal Microbiologist, QC will be responsible for setting up and maintaining QC Microbiology programs. The Principal Microbiologist will be responsible for establishing procedures to support environmental monitoring and utilities testing (water, gas and air supplies).
The Principal Microbiologist will be responsible for overseeing the Contamination Control Strategy, Environmental Monitoring Risk Assessment, and studies regarding Microbiological Assays (Bioburden, Endotoxin, Sterility).
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities:
The responsibilities of the Principal Microbiologist, QC include, but are not limited, to the following:
• Setting up and maintaining of the QC Microbiology systems
needed to enable testing requirements in support of the facility.
• Establishing and overseeing the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Oversee the environmental monitoring program including aseptic fill finish (Grade A/B) monitoring. Play a leading role in any excursions and assessing the impact.
• Continually develop the environmental monitoring program in line with regulatory requirements and industry guidance. Develop robust procedures to monitor and proactively
identify any trends.
• Play a leading role in the development of the contamination control strategy.
• Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis and raw materials testing.
• Management/planning of water sampling and associated water testing
• Ensure completion of change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
• Author QC regulatory documentation and assist in regulatory audits/inspections, as needed.
• Troubleshooting of equipment and QC methods.
• Manage / perform assay qualification, as necessary.
• Manage Microbiology related technical studies performed with external companies and review of reports.
Qualifications:
Experience and skill requirements:
• Minimum 10 years GLP/GMP laboratory-based experience in a Microbiology testing capacity in a GMP-Regulated environment.
• Good analytical skills and technical experience is a must, preferentially with previous experience setting up a testing laboratory and/or supporting a manufacturing facility.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills
• Experience in PAI, agency regulated Audits preferred
Location:
This position is based in our Framingham location and typically has a 5-day on-site expectation.
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