Job Description: QA Lead Technical Operations, Projects
STEM Diverse Talent Solutions
Contract
On-site
Devens, Massachusetts, United States
QA Lead
Job Description/ Responsibilities:
โข Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andย approval of Investigations and Corrective Actions.
โข Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
โข Reviews and approves Quality, Quality Control, Validation and Automation related documents
โข Review and approves Standard Operating Procedures (SOPs).
โข Review and approval of Validation related documentation such as risk assessments, protocols and test scripts andย summary reports.
โข Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
โข Ability to coach across different departments within the subject matter of Investigations, CAPAs, general riskย assessments and Validation.
โข Ability to self-manage and prioritize work across multiple competing deliverables, in a remote workingย environment
โข Able to interpret complicated data and make sound decisions, Independently
This position will regularly interact with:ย Reporting Manager
Sometimes will interact with departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications:
โข Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,biochemistry, or related discipline, or its equivalent is preferred.
โข Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on productย quality. Preferred Active member of ASQ or ISPE.
โข Prior experience of QC equipment Qualification and some project management experience
โข Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing isย highly desirable.
โข Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
โข Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronicย or paper-based batch records desirable.
โข Excellent Technical writing and oral communication skills are required.
โข Background in problem solving
โข Knowledge of Data integrity principles
โข Proven attention to details
โข Comfortable working in an FDA regulated environment.
โข Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andย approval of Investigations and Corrective Actions.
โข Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
โข Reviews and approves Quality, Quality Control, Validation and Automation related documents
โข Review and approves Standard Operating Procedures (SOPs).
โข Review and approval of Validation related documentation such as risk assessments, protocols and test scripts andย summary reports.
โข Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
โข Ability to coach across different departments within the subject matter of Investigations, CAPAs, general riskย assessments and Validation.
โข Ability to self-manage and prioritize work across multiple competing deliverables, in a remote workingย environment
โข Able to interpret complicated data and make sound decisions, Independently
This position will regularly interact with:ย Reporting Manager
Sometimes will interact with departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications:
โข Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,biochemistry, or related discipline, or its equivalent is preferred.
โข Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on productย quality. Preferred Active member of ASQ or ISPE.
โข Prior experience of QC equipment Qualification and some project management experience
โข Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing isย highly desirable.
โข Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
โข Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronicย or paper-based batch records desirable.
โข Excellent Technical writing and oral communication skills are required.
โข Background in problem solving
โข Knowledge of Data integrity principles
โข Proven attention to details
โข Comfortable working in an FDA regulated environment.