Careers

Position Description: Quality Assurance Associate

Job Title: Quality Assurance Associate
Location: La Jolla, CA
Department: Quality Assurance
Reports To: Quality Assurance/ Quality Systems Manager

Summary

This position supports the different activities within the Quality Assurance Department. Incumbent is responsible for extensive filing and archiving activities, record entry and maintenance of the training database. In addition, performs review of intermediate batch records and autoclave runs, and participates in projects within the QA/RA departments.

ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following, although other duties may be assigned.

Master Filing – Maintains Hardcopy Master Files up to date. Distributes new documentation and retrieval of outdated reference copies, and files the “original” documentation.

Administration and Maintenance of the Quality System documents – Issuance of lot numbered documents and forms for manufacturing, quality control and other departments on a weekly basis. Performs archiving and Device History Record filing, Off-Site storage program. Filing and Handling of QA/RA document maintenance activities. Scheduling the periodic review and coordinating with the different responsible departments to ensure compliance.

Perform Batch Record review of Intermediate Batch Records, and Autoclave Runs.

Maintain the training system. Enter training records, update training matrices and create new files for new employees in the database.

Collaborate in different projects within the QA/RA Department.

Additional assignments as directed by Supervisor.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

Associate's degree from a two-year College; or one to two years related experience and/or training; or equivalent combination of education and experience. Associate’s Degree preferred.

KNOWLEDGE AND SKILLS / ABILITIES

Requires strong personal computer skills Keyboarding, Microsoft Office Applications (Access, Excell and Word).

Must be detailed oriented , be able to follow detailed instructions, possess excellent time management skills, be well organized, a self starter and display a professional demeanor wit a high focus on customer service activities / responsibilities.

Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.

Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities.

Must have strong customer service skills.

Verbal communication skills (English)

Knowledge of Good Manufacturing Practices / Quality System Regulations and ISO Standards preferred.

Must be able to work a consistent schedule to satisfy the Customer Service responsibilities of the job.

Language Skills

Ability to read, analyze, and interpret general business procedures, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, and employees of the organization.

Mathematical Skills

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

CERTIFICATES, LICENSES, REGISTRATIONS

None required.

Physical Demands

Position requires incumbent to work with personal computers performing keyboarding / typing and data entry. Extensive filing required. Some lifting of boxes is necessary.

We are an Equal Opportunity Employer.