8 Quality Assurance Specialist Jobs in Noblesville, IN
Beacon Hill is Hiring a Quality Assurance Specialist Near Noblesville, IN
Summary of Position
The Quality Assurance Specialist position reports directly to the Manager Quality Assurance. The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.
Responsibilities
- Write, revise, review, and approve site procedures and policies.
- Review and approve investigations and associated CAPAs.
- Participates in regulatory agency (i.e., FDA, etc.) inspections.
- Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.
- Assemble, analyze, and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.
- Review Batch Records and provide final product disposition.
- Conducts internal audits of GMP Quality Systems and sub systems.
- Aide in assessing risk during Vendor Qualifications or Material Assessments.
- Conducts incoming material disposition.
- Document Control, Training, Quality Systems back-up, and key trainer.
- Reviews and assesses in-house solution preparation and external material testing.
- Conducts Vendor Qualification and reviews.
- Review and compile the Annual Product Quality Review.
- Ability to adapt quickly in a fast-paced dynamic environment.
- Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
- Bachelor's degree in Life Sciences or related field required.
- 3 years of relevant GMP Quality experience in a pharmaceutical manufacturing environment required.
- Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes, and facility systems.
- Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred.
- Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
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Job Summary
Full Time
$86k-103k (estimate)
05/03/2024
05/16/2024
beaconhillstaffing.com
BOSTON, MA
200 - 500
2000
Private
ANDREW WANG
$50M - $200M
Business Services
Related Companies
About Beacon Hill
Beacon Hill is a Massachusetts-based management consulting firm that provides staffing, recruitment and related services for businesses.
The following is the career advancement route for Quality Assurance Specialist positions, which can be used as a reference in future career path planning. As a Quality Assurance Specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Specialist. You can explore the career advancement for a Quality Assurance Specialist below and select your interested title to get hiring information.
