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QA Lead - Technical Operations

Devens, MA 01434

Posted: 01/17/2023 Job Number: 22870491

Job Description

Hybrid role- 50% onsite.
Some activities can be done remote and other activities must be done onsite.
Contractor must be able to come onsite when needed.
Work Schedule- Monday through Friday - 1st shift.
Required Skills:
  • 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.
  • 12 years of experience in a GMP, GCP, or GXP with at least 10 years focused on product quality, preferred Active member of ASQ or ISPE.
  • Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
  • 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, 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.
Project Description:
  • 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 Senior 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.
This 7+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com

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Margo Emling

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