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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
Full Time
Business Services
$86k-103k (estimate)
04/10/2024
04/23/2024
beaconhillstaffing.com
BOSTON, MA
200 - 500
2000
Private
ANDREW WANG
$50M - $200M
Business Services
Beacon Hill is a Massachusetts-based management consulting firm that provides staffing, recruitment and related services for businesses.
The job skills required for Quality assurance specialist include Quality Assurance, Product Quality, Internal Audit, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality assurance specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality assurance specialist. Select any job title you are interested in and start to search job requirements.
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.