Quality Associate
3 weeks ago
Description:
The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.
Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
Responsible for various aspects of quality assurance and quality control related to their functional area.
Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.
Support troubleshooting and resolution of quality compliance issues.
Communicates with Management for Quality Management Review, Quality Initiatives, etc.
Responsible for quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs.
Qualifications:
Bachelor's Degree with 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry
1+ years within a manufacturing facility
Must be familiar with use of electronic document management and laboratory information management.
Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
Strong communication skills, both oral and written
Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.
Some form of review experience: data or record review
Bonus: some work with investigations
Bonus: experience with document revisions
Bonus: review of GMP commercial batch records
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