BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Associate to work for a leading San Diego biotechnology company.
Duties and Responsibilities:
Reviews and releases quality system, product and process documentation for completeness, accuracy and to assure quality specifications and requirements are adequately addressed.
Confers with engineers, managers, other departments and assists in resolution of product quality or quality system issues.
Reviews and verifies documents for completeness, format, and compliance with applicable federal, international regulatory requirements and company policies.
Responsible for updating and maintaining international and domestic standards used and referenced in the development and maintenance of products.
Assist in the creation and development of product labeling.
Leads the MRB/CCB meetings.
Reviews, releases, tracks, monitors and trends Nonconforming Material Reports (NCMRs), Change Orders, Complaint, RGAs and Corrective Actions.
Responsible for closing Change Orders when implementation tasks are completed.
Responsible for the distribution of all controlled documents to Engineering, Manufacturing and Quality Departments and external suppliers.
Responsible for the creation and maintenance of Material Master numbering system.
Ensures that all applicable employees have received and returned training documents. Verifies that all training records have been updated.
Performs duties in compliance and ensures compliance with relevant QSRs, ISO regulations and the MDD for area of responsibility.
Performing and completing various miscellaneous tasks when assigned.
Skills and Abilities:
Listen and understand verbal and written instructions.
Take the initiative to organize the workload.
Ability to set priorities and work them through.
Ability to work under tight deadline.
Good communication skills and a team oriented attitude.
Computer knowledge working within multi-level network platforms.
Individual must be detail oriented, accurate, well organized and able to work effectively under pressure and constant changing priorities. The employee must be able to develop and maintain positive relationships with employee population.
The ideal candidate for this position must have a commitment to high quality standards.
Education: 2 year technical degree (AS) or equivalent combination of experience and education.
1-2 years manufacturing experience, ideally in a medical manufacturing environment. 1 year of experience in Documentation Control preferred.
Basic knowledge of FDA QSRs, ISO 9001 and ISO 13485.
Must be proficient in computer skills. Experience using Microsoft Word and Excel. MS Access highly desirable.
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