QC Analyst

Job Opening for QC Analyst, Lexington, MA
We are currently working on below mentioned job opening i.e Job Opening for QC Analyst, Lexington, MA . Please let me know if you are interested in applying for the same.
Senior QC Analyst – Bioassay and Virology will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This position is based at a new state of the art facility in Lexington, MA.
This role supports the day-to-day operations within the Quality Control Group via execution of analytical testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. This role will also train staff in support of Quality Control testing. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
•    Perform routine and non-routine testing of in-process, drug substance, and final product samples in accordance with Standard Operating Procedures. Examples of test methods include
o    Potency
o    TCID50
o    Infectivity
o    qPCR, ddPCR
o    Morphological and Growth Characteristics of Working and Master Cell Banks.
o    ELISA
•    Virus and Cell banks
•    Participate in equipment validation and method transfer activities
•    Revise, review and maintain standard operating procedures.
•    Execute change control
•    Investigate deviations, out of specification results and out of trend results.
•    Maintenance of laboratory equipment/instrument and systems to ensure compliance.
•    May generate protocols and reports as required.
•    Training of other QC Analysts within the department.
•    Troubleshoot equipment and analytical testing methods.
•    Perform all work in accordance with current Good Manufacturing Practices (cGMP).
•    Other tasks, as assigned.

Experience and Skill Requirements:
•    BA or BS in Biochemistry/Molecular Biology or other related science.
•    Minimum 5 years of analytical and/or cell based laboratory experience within QC testing capacity, preferably in GLP/cGMP environment.
•    High proficiency in mammalian and insect cell culture.
•    Excellent analytical and relevant instrumentation skills such as PCR, ELISA and Gel Electrophoresis, etc.
•    Thorough understanding of industry testing requirements/standards.
•    Computer literacy (MS Word, Excel, and LIMS).
•    Good/effective communication and organizational skills with the ability to work well with others and independently

Job Opening for QC Analyst, Lexington, MA
We are currently working on below mentioned job opening i.e Job Opening for QC Analyst, Lexington, MA . Please let me know if you are interested in applying for the same.
Senior QC Analyst – Bioassay and Virology will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This position is based at a new state of the art facility in Lexington, MA.
This role supports the day-to-day operations within the Quality Control Group via execution of analytical testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. This role will also train staff in support of Quality Control testing. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
•    Perform routine and non-routine testing of in-process, drug substance, and final product samples in accordance with Standard Operating Procedures. Examples of test methods include
o    Potency
o    TCID50
o    Infectivity
o    qPCR, ddPCR
o    Morphological and Growth Characteristics of Working and Master Cell Banks.
o    ELISA
•    Virus and Cell banks
•    Participate in equipment validation and method transfer activities
•    Revise, review and maintain standard operating procedures.
•    Execute change control
•    Investigate deviations, out of specification results and out of trend results.
•    Maintenance of laboratory equipment/instrument and systems to ensure compliance.
•    May generate protocols and reports as required.
•    Training of other QC Analysts within the department.
•    Troubleshoot equipment and analytical testing methods.
•    Perform all work in accordance with current Good Manufacturing Practices (cGMP).
•    Other tasks, as assigned.

Experience and Skill Requirements:
•    BA or BS in Biochemistry/Molecular Biology or other related science.
•    Minimum 5 years of analytical and/or cell based laboratory experience within QC testing capacity, preferably in GLP/cGMP environment.
•    High proficiency in mammalian and insect cell culture.
•    Excellent analytical and relevant instrumentation skills such as PCR, ELISA and Gel Electrophoresis, etc.
•    Thorough understanding of industry testing requirements/standards.
•    Computer literacy (MS Word, Excel, and LIMS).
•    Good/effective communication and organizational skills with the ability to work well with others and independently