Overview
QA Support Specialist Jobs in Santa Ana, USA at Merck & Co.
Position Overview
We are hiring a QA Support Specialist. The QA Support Specialist will support external and internal requests for quality information. They will also help manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions.
Shift: 8am to 5pm
Responsibilities
- Helps customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.)
- Acts as customer liaison for internal inquiries and provides voice of customer
- Coordinates customer surveys and questionnaire completion
- Assists with supplier questionnaires and qualification
- Assists with customer audits and follow up actions
- Assists with change notification and supplier management
- Assists with batch record review or other duties as needed
- Assists with coordination of quality activities for related FISI production site
Required Skills/Education
- BS/BA in Biology, Microbiology, or Chemistry
- 3-5 years of QA experience in medical device or biopharmaceutical environment
- Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
- Excellent computer skills including MS Word, Excel, Power Point
- Ability to speak, read, and write proficiently in English.
- Good oral and written communication skills.
Salary and Benefits
- For California, the base salary range for this position is $31.11 – $35.00 per hour. Compensation will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
- Medical, Dental, Vision
- Life Insurance
- 401k
- Paid Time Off
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().
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Title: QA Support Specialist
Company: Merck & Co.
Location: Santa Ana, USA
Category:
