Overview
On Site
USD 64.00 - 65.00 per hour
Contract - W2
Skills
Pharmaceutics
Recruiting
QA Management
IT Operations
SAP BASIS
Mergers and Acquisitions
Science
Biology
Biochemistry
GMP
Google Cloud Platform
Google Cloud
GxP
Project Management
Manufacturing
Medical Devices
Analytical Skill
Testing
Good Manufacturing Practice
GAMP
SAP
LIMS
Trackwise
Veeva
Technical Writing
Communication
Problem Solving
Conflict Resolution
Data Integrity
Quality Assurance
Reporting
Decision-making
Quality Management
Quality Control
Standard Operating Procedure
Documentation
Test Scripts
Risk Assessment
Management
Collaboration
Job Details
Our client, a leading pharmaceutical company, is hiring a QA Lead - Technical Operations, on a contract basis.
Job ID: 82974
Work Location:
Devens, MA - on site
Education/Experience:
Knowledge/Skills:
Responsibilities:
Pay: $64-$65/hr
The post appeared first on .
Job ID: 82974
Work Location:
Devens, MA - on site
Education/Experience:
- 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, Google Cloud Platform, 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.
Knowledge/Skills:
- Quality Control Equipment experience preferred
- Technical Writer
- Investigations/Deviation experience preferred
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
Pay: $64-$65/hr
The post appeared first on .
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