Maintains quality compliance by identifying quality
requirements; disseminating standards, policies, and procedures; conducting
audits; recommending improvement plans, well versed in FDA 21 CFR 110 &
111. Competent and well organized to not only write quality standard
procedures but also improve current ones. Communication/Training skills
also a must.
* Identifies quality requirements by reviewing
regulations, guidelines, and standards, including International Committee
on Harmonisation (ICH), International
Organization on Standardization (ISO), and Environmental Protection Agency
(EPA), Food & Drug Administration (FDA), Good Manufacturing Practices
(GMP), Dept. of Agriculture (DoA)
* Communicates quality goals and requirements by
preparing and disseminating standards, metrics, standard operating
procedure (SOP) management, and contractor document and production records
* Assesses quality compliance by conducting audits;
analyzing and verifying documentation; reviewing process changes.
* Improves quality compliance by recommending and
following-up on improvement plans; writing training courses; contributing
information to cross-functional quality improvement teams.
* Prepares quality assurance reports by collecting,
analyzing, and summarizing data and trends.
* Protects organization's competitiveness by keeping
* Updates job knowledge by reviewing changes in good
manufacturing practices (GMP), good laboratory practices (GLP), and
regulatory requirements; participating in educational opportunities;
reading professional publications.
* Up to date knowledge of current regulations,
including FSMA (Food Safety Modernization Act)
* Enhances department and organization reputation by
accepting ownership for accomplishing new and different requests; exploring
opportunities to add value to job accomplishments.
Quality Management, GCP, Documentation Skills, Reporting
Skills, Analyzing Information , Problem Solving, Process Improvement,
Verbal Communication, Informing Others, Attention to Detail, Biohazard
Safety, Allergen Safety, Labeling Compliance, Dietary Supplement
Job Type: Full-time
Salary: $45,000.00 to $60,000.00 /year
- Quality Assurance: 2 years