Qa Auditor II

Compensation

: $91,400.00 - $141,030.00 /year *

Employment Type

: Full-Time

Industry

: Accounting



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An opportunity has arisen for a QA Auditor II in the Quality Assurance Unit. The Quality Assurance Unit ensures all quality policies, procedures and processes
are in compliance with US-FDA, US-DEA and EMA regulations.
DUTIES
Ensure compliance with US FDA, US DEA and EMA regulations
Review/approval of GMP Analytical Reports and associated electronic and hard copy data, audit trails and notebooks
Review/approval of internal records such as
Instrument calibration and maintenance
Training records
Laboratory investigations, NOrganization, Complaints, Change Control
Internal audits
Review of root cause analyses, risk assessments and analyses, corrective and preventive actions, CAPA effectiveness checks
Review/comment on site SOPs
Assists with internal, client, vendor and compliance audits
Assists in policy and procedure development
Responsible for Corrective Actions Preventative Actions (CAPA)
Responsible for DEA activities
Assists with computer compliance/data integrity
Assist with monitoring and managing KPIs.
Qualifications
Knowledge of analytical chemistry, demonstrated through BA/BS Chemistry, Biology or related scientific degree
Minimum of 4 years of related (regulated GXP) industry experience in an analytical laboratory
Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
Experience in Laboratory GMP environment is a plus
Organization, communication and analytical skills
Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
Intermediate mathematical skills, including algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to work varied and extended hours/days, as business dictates


Associated topics: automation, prevention, quality, quality assurance, quality assurance analyst, software quality, software quality assurance, software quality engineer, software quality assurance engineer, test engineer * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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