QA Lead Technical Operations, Projects - TechDigital
Devens, MA
About the Job
QA Lead Technical Operations, Projects
Onsite, Devens location
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
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
Onsite, Devens location
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
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
Source : TechDigital