Our client, a leading pharmaceutical company, is hiring a QA Lead Technical Operations consultant on a contract basis.
Hybrid role- Minimum 50% onsite and some activities can be done remote and other activities must be done onsite
• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
• 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
Preferred some project management experience.
This position will regularly interact with:
Reporting Senior Manager
Sometimes will interact with departments listed below:
Manufacturing Science and Technology (MS&T)
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.
• Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.
• 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.
Pay Range: $65-$67