Bioassay Review Specialist
4 weeks ago
Job Title: Reviewer I, Bioassay
Location: Norwood MA
Pay Rate: $45-52/hr
We are seeking a Quality Control Chemistry Data Review Associate I based at Norwood laboratory, MA sites. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support special projects as needed.
Here’s What You’ll Do:
· Performs routine analytical chemistry data review and reporting of data generated through the laboratory tests including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc.
· Perform data review in LIMS and in paper worksheets if applicable.
· Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.
· Communicate the OOS/OOT/OOE/LE/Deviation cases to quality event investigation team promptly to ensure the Chemistry lab comply with investigation/deviation SOP procedures.
· Ensures timely and successful execution of the assigned data review and data management task.
· Interact with other analysts when corrections are identified as part of the data review process.
· Performs data entry and supports trending and analysis as applicable.
· Perform and/or support Certificate of Analysis generation as needed.
· Participates in project meetings to provide status updates to stakeholders.
· Provides prompt communication of risk and mitigation for all data management related deliverables.
· Work on continuous improvement for data review requirements and processes to ensure delivery of highest quality of data.
· Complete and maintain cGMP documentation (electronic and Hard Copy) for laboratory raw data packets.
· Establish and maintain a safe working environment
Here’s What You’ll Bring to the Table:
· Minimum education required: Bachelor’s degree in a relevant scientific discipline, preferred in Chemistry.
· Minimum experience required: 2-5 years in a laboratory setting with focus in pharmaceutical QC analytical chemistry
Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.-
Bioassay Reviewer
2 weeks ago
Norwood, United States Global Technical Talent Full timeBioassay Reviewer Contract Duration 6 Months Pay range - $0.69 to $55/hr Job Description: In this role, the Bioassay Reviewer will support QC Bioassay Labs with a review of test records and documents. Job Responsibilities: Review executed QC test records for molecular and cell-based assays Review Audit trails Review reagent and equipment logbooks...
-
quality control, bioassay data reviewer
1 week ago
norwood, United States Randstad US Full timequality control, bioassay data reviewer. + norwood , massachusetts + posted march 27, 2024 **job details** summary + $45 - $50 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference47779 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to...
-
Data Review, Quality Control Bioassay
1 week ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, the QC Bioassay Data Reviewer will support data and records review in LIMS, Veeva, and assay worksheets. Additionally, this role is responsible for review of department logbooks.Heres What Youll Do Review executed QC test records (paper and electronic records) Review audit trails Review reagent and equipment logbooks Record and...
-
Data Review, Quality Control Bioassay
7 days ago
Norwood, United States BioSpace Full timeJob DetailsThe RoleIn this role, the QC Bioassay Data Reviewer will support data and records review in LIMS, Veeva, and assay worksheets. Additionally, this role is responsible for review of department logbooks.Heres What Youll DoReview executed QC test records (paper and electronic records)Review audit trailsReview reagent and equipment logbooksRecord and...
-
Quality Control Data Reviewer
1 month ago
Norwood, United States Randstad Life Sciences US Full time6 Month ContractNorwood, MAPR: $45-50/hurShift: 1st Shift, M-FJob SummaryIn this role, you will support QC Bioassay Labs with review of test records and documents.Job ResponsibilitiesReview executed QC test records for molecular and cell based assaysReview Audit trailsReview reagent and equipment logbooksAdditional duties may be assigned Education &...
-
Quality Control Data Reviewer
1 month ago
Norwood, United States Randstad Life Sciences US Full time6 Month ContractNorwood, MAPR: $45-50/hurShift: 1st Shift, M-FJob SummaryIn this role, you will support QC Bioassay Labs with review of test records and documents.Job ResponsibilitiesReview executed QC test records for molecular and cell based assaysReview Audit trailsReview reagent and equipment logbooksAdditional duties may be assigned Education &...
-
Quality Control Data Reviewer
2 weeks ago
Norwood, United States Randstad Life Sciences US Full time6 Month ContractNorwood, MAPR: $45-50/hurShift: 1st Shift, M-FJob SummaryIn this role, you will support QC Bioassay Labs with review of test records and documents.Job ResponsibilitiesReview executed QC test records for molecular and cell based assaysReview Audit trailsReview reagent and equipment logbooksAdditional duties may be assigned Education &...
-
Quality Control, Bioassay Data Reviewer
1 month ago
Norwood, United States Randstad North America, Inc. Full timeAs the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a la Quality Control, Data, Technology, Staffing
-
Chemistry Data Reviewer
1 week ago
Norwood, United States GTT, LLC Full timeChemistry Data Reviewer / Quality Control Sample Management Associate Contract Duration 6+ months Pay rate up to $0.69 - $42.22/hr The Role Our client is seeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC...
-
Sr QC Microbiologist
3 weeks ago
Norwood, United States Connexion Systems & Engineering, Inc. Full timeJob DescriptionJob DescriptionTitle: Reviewer, BioassayHiring Organization: Connexion Systems & EngineeringPay rate: $45-52/hrJob Location: Canton, MAJob# 16653In this role, you will support QC Bioassay Labs with review of test records and documents.Here’s What You’ll DoReview executed QC test records for molecular and cell based assaysReview Audit...
-
Specialist, Quality Assurance
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeSpecialist, Quality Assurance6 Month Initial ContractNorwood, MA | Onsite Max PR: $50 per hourImmediate Need for an Internal Quality Assurance Specialist in Norwood MassachusettsMUST HAVE'sWilling to to work 100% on-site in Norwood, MA2-4 years of experience in quality oversight or manufacturing experience in early stage clinical productsExperience executing...
-
Specialist, Quality Assurance
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeSpecialist, Quality Assurance6 Month Initial ContractNorwood, MA | Onsite Max PR: $50 per hourImmediate Need for an Internal Quality Assurance Specialist in Norwood MassachusettsMUST HAVE'sWilling to to work 100% on-site in Norwood, MA2-4 years of experience in quality oversight or manufacturing experience in early stage clinical productsExperience executing...
-
Specialist, Quality Assurance
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeSpecialist, Quality Assurance6 Month Initial ContractNorwood, MA | Onsite Max PR: $50 per hourImmediate Need for an Internal Quality Assurance Specialist in Norwood MassachusettsMUST HAVE'sWilling to to work 100% on-site in Norwood, MA2-4 years of experience in quality oversight or manufacturing experience in early stage clinical productsExperience executing...
-
Sr. Project Manager for FLAIR
1 week ago
Norwood, United States Global Technical Talent Full timeChemistry Data Reviewer / Quality Control Sample Management Associate Contract Duration 6+ months Pay rate up to $0.69 - $42.22/hr The Role Our client is seeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry,...
-
Senior Quality Assurance Specialist
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeTitle: QA Quality Systems and DistributionDuration: 06 months Contract Location: Norwood, MAMax PR: $55.00Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as neededAdministration support for documentation archive in Veeva eQMSEnsure compliance...
-
Senior Quality Assurance Specialist
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeTitle: QA Quality Systems and DistributionDuration: 06 months Contract Location: Norwood, MAMax PR: $55.00Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as neededAdministration support for documentation archive in Veeva eQMSEnsure compliance...
-
Senior Quality Assurance Specialist
2 weeks ago
Norwood, United States Randstad Life Sciences US Full timeTitle: QA Quality Systems and DistributionDuration: 06 months Contract Location: Norwood, MAMax PR: $55.00Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as neededAdministration support for documentation archive in Veeva eQMSEnsure compliance...
-
Senior Quality Assurance Specialist
1 week ago
Norwood, United States Randstad Life Sciences US Full timeTitle: QA Quality Systems and DistributionDuration: 06 months Contract Location: Norwood, MAMax PR: $55.00Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as neededAdministration support for documentation archive in Veeva eQMSEnsure compliance...
-
Quality Systems and Distribution Specialist
3 days ago
Norwood, United States Randstad Life Sciences US Full time6 Month ContractNorwood, MA - Preference is on-site but it can be REMOTEPR: $37-47/hour if Remote, $50-60/hour if on-site Shifts:M-F, 8 hour shiftsORWed-Sat, 10 hour shifts Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as...
-
Quality Systems and Distribution Specialist
2 days ago
Norwood, United States Randstad Life Sciences US Full time6 Month ContractNorwood, MA - Preference is on-site but it can be REMOTEPR: $37-47/hour if Remote, $50-60/hour if on-site Shifts:M-F, 8 hour shiftsORWed-Sat, 10 hour shifts Job ResponsibilitiesPerform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as...