QA Lead Technical Operations, Projects - TechDigital Corporation
Devens, MA
About the Job
Job Description/ Responsibilities:
" Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
approval of Investigations and Corrective Actions.
" Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
" Reviews and approves Quality, Quality Control, Validation and Automation related documents
" Review and approves Standard Operating Procedures (SOPs).
" Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and
summary reports.
" Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
" Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk
assessments and Validation.
" Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working
environment
" Able to interpret complicated data and make sound decisions, Independently
This position will regularly interact with:
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:
" 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.
" Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
quality. Preferred Active member of ASQ or ISPE.
" Prior experience of QC equipment Qualification and some project management experience
" Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is
highly desirable.
" Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
" Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic
or paper based batch records desirable.
" Excellent Technical writing and oral communication skills are required.
" Background in problem solving
" Knowledge of Data integrity principles
" Proven attention to details
" Comfortable working in an FDA regulated environment.
Contractor must be able to come onsite Monday through Friday - 1st shift
" Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
approval of Investigations and Corrective Actions.
" Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
" Reviews and approves Quality, Quality Control, Validation and Automation related documents
" Review and approves Standard Operating Procedures (SOPs).
" Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and
summary reports.
" Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
" Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk
assessments and Validation.
" Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working
environment
" Able to interpret complicated data and make sound decisions, Independently
This position will regularly interact with:
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:
" 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.
" Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
quality. Preferred Active member of ASQ or ISPE.
" Prior experience of QC equipment Qualification and some project management experience
" Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is
highly desirable.
" Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
" Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic
or paper based batch records desirable.
" Excellent Technical writing and oral communication skills are required.
" Background in problem solving
" Knowledge of Data integrity principles
" Proven attention to details
" Comfortable working in an FDA regulated environment.
Contractor must be able to come onsite Monday through Friday - 1st shift
Source : TechDigital Corporation
