Description
JOB SUMMARY
Performs Acceptable Quality Limit (AQL) assessments during incoming material release, post visual inspection, and post packaging. Perform periodic retention inspections and routine document reviews.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Perform the incoming component AQL inspection, upholding procedures and processes for AQL.
- May perform material release or similar duties
- Communicate effectively with manufacturing to prioritize AQL inspections Perform routine GMP document reviews (inventory cards, logbooks etc.)
- Perform material and component retention inspection.
- Keep abreast to GRAM standards and trends with regards to visual inspection of components.
- Provide input into SQIRs, CAPAs, Customer Complaints, and Deviation Investigations from the visual inspection aspect.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Open to a flexible and fluid work environment.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
Requirements
DESIRED SKILLS & ABILITIES
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Demonstrates confidence in decision making ability.
- Takes accountability and ownership of the AQL process.
- Ability to work independently and participate in a cross-functional team environment.
- Must have basic computer skills in Microsoft Word, Excel and Outlook.
Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. This level of knowledge is normally acquired through completion of a HS Diploma/GED. Previous visual inspection or quality assurance experience is desirable
GRAM supports Equal Opportunity Employment