Job Description

Multiple sites QAA needed. We are seeking an Entry Level High Energetic Quality Assurance Assistant to complete various task in the Quality Assurance proving well rounded experience in ISO procedures:

DESCRIPTION

The QAA shall assist the QA manager in the coordination of the activities necessary to satisfy the quality standards and the quality policy, support improvement and containment actions related to products/processes through the analysis of non-conformities and customer complaints, collaborate in the maintenance of the QMS documentation in accordance with ISO

Copan Diagnostics is a global leader in sample collection and transport systems, with a major role in providing test kits for the Covid-19 pandemic and leading the industry in laboratory automation. Past 90-days of probation, working from home will be approved on a case-by-case basis by the quality manager. Paid training is provided on a yearly basis on ISO 13485:2016 and other relevant skills as deemed necessary by management.

RESPONSIBILITIES

• Performs timely review of batch production records; assures that batch records are complete, correct, and meet all pertinent documentation requirements.
• Identifies in-house quality issues.
• Assists with product nonconformance investigations.
• Maintains quality assurance databases, reports, and files.
• Prepares, performs, and documents personnel training to ensure personnel has the appropriate training and understanding of QA systems.
• Assists in the review of all supporting documentation including but not limited to area and equipment logbooks, cleaning logs, and environmental monitoring data.
• Assists in QA release of products for distribution.
• Verifies product release status for other departments; completes all appropriate release checklists and certifications.
• Maintains instrument calibration certificates and calibration schedule.
• Assists with management reports; area clearances; analysis of quality indicating data trends; preparation of annual product reviews; investigation of deviations, variances, and product complaints; preparation of SOPs, laboratory investigations, and training syllabi as needed.

EDUCATION/EXPERIENCE

• Bachelor’s or master’s degree preferably in chemical engineering, biology, pharmacy, chemistry and applied technology, biotechnology, and biochemical engineering.
• Two years of related experience required

QUALIFICATIONS /SKILLS

• Knowledge about the procedures related to the specific job position.
• Fluent in English, good Spanish preferred.
• Knowledge of ISO 13485:2016, ISO 9001:2015, and CFR 21
• Analyze data on internal, external nonconformities and client complaints.
• Ability to effectively formalize production and control instructions and behavioral rules
• Basic knowledge of SAL, sterilization, bioburden, dosimetry control, and biological indicators meaning.

Company Description

Be a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for automatic segregation of bacterial cultures, followed by automated colony picking.