Quality Assurance Specialist

Beacon Hill - Job Details
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Quality Assurance Specialist

Noblesville, Indiana

|

Full Time

|

$ 34 - $ 37 per hour

Noblesville, Indiana

Full Time

$ 34 - $ 37 per hour

April 01, 2024

|

Job ID: LS1371743NJN-HR_1711984528

April 01, 2024

Job ID: LS1371743NJN-HR_1711984528

Job Summary

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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.

Qualifications

  • 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.
LS1371743NJN-HR_1711984528

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™