Quality - QC Lab Systems Specialist - TechDigital
Devens, MA
About the Job
100% Onsite!
JOB SUMMARY
Client is seeking a QC Specialist for QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA. The QC Specialist is responsible for supporting Quality Control analytical data review for in-process and final drug substance methods as well as supporting data trending and report generation. This includes the ability to interface with multiple groups, the ability to independently review, interpret results, troubleshoot, and initiate and own deviations. The QC Specialist role is stationed in Devens, MA and reports to the Senior Manager, QC Analytical for the Devens CTF.
JOB RESPONSIBILITIES
Perform data review for in-process and final drug substance methods in support of routine manufacturing following applicable procedures and SOPs.
Perform routine data analysis including trending requirements and report generation to support quarterly data trending requirements.
Initiate and own non-impact laboratory deviations.
Document data GMP accurately and within the proper system.
Anticipate and troubleshoot problems.
Support document revisions, projects, and related tasks.
Perform assigned tasks within a CAPA, deviation, or project.
Participate in projects and continuous improvement efforts.
Other duties as assigned.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Bachelor's degree required, preferably in science.
2+ years of relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitute.
Experience working in a GMP laboratory and with cell therapy products preferred.
Experience with analytical laboratory testing techniques and deviations writing preferred.
Knowledge of aseptic technique within a laboratory environment is preferred.
Hands on experience with various analytical techniques including FLOW Cytometry, and PCR based methods is preferred.
Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
Strong technical writing skills.
Problem-solving ability/mentality, technically adept and logical.
Ability to communicate effectively with peers, department management and cross-functional peers.
Knowledge of LIMS and laboratory data analysis systems preferred.
JOB SUMMARY
Client is seeking a QC Specialist for QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA. The QC Specialist is responsible for supporting Quality Control analytical data review for in-process and final drug substance methods as well as supporting data trending and report generation. This includes the ability to interface with multiple groups, the ability to independently review, interpret results, troubleshoot, and initiate and own deviations. The QC Specialist role is stationed in Devens, MA and reports to the Senior Manager, QC Analytical for the Devens CTF.
JOB RESPONSIBILITIES
Perform data review for in-process and final drug substance methods in support of routine manufacturing following applicable procedures and SOPs.
Perform routine data analysis including trending requirements and report generation to support quarterly data trending requirements.
Initiate and own non-impact laboratory deviations.
Document data GMP accurately and within the proper system.
Anticipate and troubleshoot problems.
Support document revisions, projects, and related tasks.
Perform assigned tasks within a CAPA, deviation, or project.
Participate in projects and continuous improvement efforts.
Other duties as assigned.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Bachelor's degree required, preferably in science.
2+ years of relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitute.
Experience working in a GMP laboratory and with cell therapy products preferred.
Experience with analytical laboratory testing techniques and deviations writing preferred.
Knowledge of aseptic technique within a laboratory environment is preferred.
Hands on experience with various analytical techniques including FLOW Cytometry, and PCR based methods is preferred.
Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
Strong technical writing skills.
Problem-solving ability/mentality, technically adept and logical.
Ability to communicate effectively with peers, department management and cross-functional peers.
Knowledge of LIMS and laboratory data analysis systems preferred.
Source : TechDigital