Tandym Group
Quality Control Analyst
Tandym Group, Woburn, Massachusetts, us, 01813
We have a current opportunity for a
Quality Control Analyst
on a contract basis. The position will be based in Woburn, MA. For further information about this position please apply.
JOB DESCRIPTION/ JOB SUMMARYThe Quality Control Analyst will be responsible for:Performing Routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stabilityReview and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platformsSupport and lead QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc.)Author and support quality events; Change Controls, Deviation, CAPA, OOS Investigation, as neededSupport method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programsAuthor analytical method performance trend reports, as neededWrite, prepare, and present technical data, technical reports, and standard operating procedures (SOPs)Model leadership behaviors and mentor/train junior staffWork with cross functional teams with both internal and external stakeholders
REQUIREMENTS / QUALIFICATIONSBS in Cell Biology, Biochemistry or a related discipline with minimum 5+ years industry experienceExperience in a GMP/GLP environment is a mustExperience in a routine mammalian cell culture requiredExperience with quantitative PCR requiredExperience with cell-based potency assays requiredExperience performing immunoassays such as ELISAs strongly desiredExperience with statistical analysis (SoftMax, JMP) preferredStrong collaboration, team-working skills, and communication skillsIndependently motivated and detail-oriented with good problem-solving abilityStrong communication, interpersonal and organizational skills
Quality Control Analyst
on a contract basis. The position will be based in Woburn, MA. For further information about this position please apply.
JOB DESCRIPTION/ JOB SUMMARYThe Quality Control Analyst will be responsible for:Performing Routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stabilityReview and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platformsSupport and lead QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc.)Author and support quality events; Change Controls, Deviation, CAPA, OOS Investigation, as neededSupport method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programsAuthor analytical method performance trend reports, as neededWrite, prepare, and present technical data, technical reports, and standard operating procedures (SOPs)Model leadership behaviors and mentor/train junior staffWork with cross functional teams with both internal and external stakeholders
REQUIREMENTS / QUALIFICATIONSBS in Cell Biology, Biochemistry or a related discipline with minimum 5+ years industry experienceExperience in a GMP/GLP environment is a mustExperience in a routine mammalian cell culture requiredExperience with quantitative PCR requiredExperience with cell-based potency assays requiredExperience performing immunoassays such as ELISAs strongly desiredExperience with statistical analysis (SoftMax, JMP) preferredStrong collaboration, team-working skills, and communication skillsIndependently motivated and detail-oriented with good problem-solving abilityStrong communication, interpersonal and organizational skills