The Quality Assurance Associate (QAA) at a medical biomaterials company is responsible for general office duties and document control within the quality and regulatory department. The individual will input information into databases, create files, assign control numbers, archive documents, file documents, do general clerical duties, and be responsible for maintaining controlled documents, document control orders (DCO), and document databases. Reports to the Document Control Manager.
The QAA shall comply with our quality system and be committed to complying with 21 CFR Part 820, Part 1271, ISO 13485, Medical Device Directive 93/42/EEC (Amendment 2007/47/EC), AATB standards, and other applicable requirements and regulations. This is an exempt individual contributor-level position.
- Perform all activities for the control and maintenance of documents and records for the quality and regulatory department. (This includes, but is not limited to, creating files, generating product batch records, updating device manufacturing records, and archiving documents.)
- Assist the document control manager in processing DCOs, as well as maintaining all standard operating procedures, work instructions, forms, and other documents in files, binders, and work areas.
- Controls number assignment for validations, qualifications, studies, test methods, and other protocols/reports, as well as equipment number assignment and part numbers.
- Maintain and record all allograft reply cards, prepare trends and produce applicable graphs.
- Provide support in component and final release of products.
- Must have a high school diploma.
- At least 2 years of experience in data entry, filing, and clerical experience.
- Minimum 1 year of experience in the quality assurance field.
- Ability to read and interpret complex medical documents, procedures, standards, regulations, etc.
- Knowledge of quality systems and cGMP standards including but not limited to 21 CFR Part 820, 21 CFR 1271, AATB, ISO 13485, and MDD 93/42/EEC are preferred.
- Ability to prioritize projects and adapt to shifting priorities.
- Strong knowledge of standard PC-based Microsoft Office applications.
- Excellent written and verbal communication skills.
$25 - $30 hourly
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