Quality/Regulatory Compliance Analyst


: $157,450.00 - $157,450.00 /year *

Employment Type

: Full-Time


: Legal

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Job Description:

The Quality Assurance Specialist II oversees requirements for continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance.

Works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to support all daily operational activities.

Job responsibilities:

Functions as an information source to various company departments when special and critical quality issues occur.

Conducts internal audits of production facilities assuring company standards and product integrity are maintained.

Consults with management to resolve quality, production, and efficiency problems.

Functions in conjunction with manager and functional experts on special department projects.

Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.

Performs the essential duties and responsibilities as listed in section below.

Writes and revises operating procedures

Conducts training for staff at all levels as it relates to quality systems

Processes document change requests and training records

Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management

Compiles information for Quality Management Review

Conducts inspections of materials

Reviews records for compliance such as inspection reports, test records, and Device History Records

Updates component, product, and documentation databases

Reviews validation/qualification reports for GMP and quality system compliance

Conducts complaint investigations

Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews

Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings

Evaluates supplier quality performance and conducts periodic evaluations of suppliers

Conducts internal audits

Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses

Other duties may be assigned as necessary

Job requirements:

Associates Degree with related work experience is required. A Bachelor s Degree is preferred.

A minimum of 4 years experience in a Quality/Regulatory Compliance environment.

Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.

Moderate computer competence, including experience with database and Microsoft Office.

Knowledge of QA terms, tools, and methodologies.

Associated topics: business, company, compliance, compliance office, corporate attorney, counsel, court, lawyer, legal, llp * 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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