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Quality assurance specialist
Beacon Hill Noblesville, IN
$86k-103k (estimate)
Full Time | Business Services 2 Weeks Ago
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Beacon Hill is Hiring a Quality assurance specialist Near Noblesville, IN

To Apply for this Job Click Here Summary of PositionThe 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.

ResponsibilitiesWrite, 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.

QualificationsBachelor'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.

Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.

LS1371743NJN-HR 1711984528 To Apply for this Job Click Here

Last updated : 2024-04-08

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$86k-103k (estimate)

POST DATE

04/10/2024

EXPIRATION DATE

04/23/2024

WEBSITE

beaconhillstaffing.com

HEADQUARTERS

BOSTON, MA

SIZE

200 - 500

FOUNDED

2000

TYPE

Private

CEO

ANDREW WANG

REVENUE

$50M - $200M

INDUSTRY

Business Services

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About Beacon Hill

Beacon Hill is a Massachusetts-based management consulting firm that provides staffing, recruitment and related services for businesses.

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