28 QA Lead Technical Operations Jobs in Devens, MA
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QA Lead Technical Operations
$111k-134k (estimate)
Other
3 Months Ago
Axelon Services Corporation is Hiring a QA Lead Technical Operations Near Devens, MA
Job Description: 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.
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.
Job Summary
JOB TYPE
Other
SALARY
$111k-134k (estimate)
POST DATE
03/10/2023
EXPIRATION DATE
10/02/2024
WEBSITE
axelon.com
HEADQUARTERS
New York, NY
SIZE
500 - 1,000
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