Quality Validation Engineer
Company: Kelly Services
Posted on: September 22, 2022
Quality Validation Engineer - Cambridge, MAFull-time, Contract
position - 12+ monthsPay - $60-$70/hrShift Hours: 8-5pm 100% onsite
Key Objectives of the role:
- Supports the manufacturing process owners and other functional
area managers as a Quality Assurance Validation subject matter
- Provides Quality support for complex cross-functional
investigations in a variety of subject matter area to determine
root cause and corrective actions.
- Develops improvements to the Quality Management System to
enhance compliance with regulatory requirements.
- QA oversight for investigations to deviations and
non-conformances identifying root cause, corrective/preventive
actions, and effectiveness of actions taken.
- Reviews and approves quality records, validation protocols,
standard operating procedures, Work Orders, Preventative
Maintenance activities, Calibration activities, changes to
procedures and processes to ensure compliance with required
- Contributes expert process knowledge for product and process
design and validation teams.
- Works directly with customers (internal, external, suppliers)
on complex critical to quality issues.
- Quality oversight for cross-functional team projects (R&D,
Mfg, Vendors, etc).
Minimum Qualifications (must have):
- Bachelor's degree in engineering or Science Discipline with
minimum 5 years of experience or High School Diploma with 8 years
of experience within the Pharmaceutical Industry supporting the
manufacture of Regulated Product.
- Advanced knowledge of Quality Engineering principles and
practices in a FDA Regulated Environment.
- Proficient in team building and leading product quality
- Technical report documentation and authoring procedures.
- Analytical Instrument Validation,
- Analytical Method Validation,
- Process Validation #P2
Keywords: Kelly Services, Cambridge , Quality Validation Engineer, Engineering , Cambridge, Massachusetts
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