QA Product Release Coordinator I

We are hiring a Quality Assurance Product Release Coordinator. The Quality Assurance Product Release Coordinator will ensure quality of product by performing reviews of batch records and applicable documentation. Ensures quality is present through a review of all documentation, labeling, and storage conditions for in-process and final products in accordance with Standard Operating Procedures. Ensures compliance with ISO 9001 and applicable standards/regulations.

• Review and verify all documentation in batch records
• Update and maintain the QA Database
• Report deviation and nonconformance observed during product releases
• Inspect the labeling and storage conditions of the product
• Assist in the preparation of all controlled documents (generating DCRs as needed)
• Review and improve processes as needed (provide training as needed)
• Assist the Document Control department as needed
• Collaborate with other departments to meet customer requests
• Other duties as assigned

• High school diploma or equivalent; basic understanding of mathematics and chemistry necessary
• Two years of college in a science discipline is preferred
• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
• Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook
• Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations and inspection and auditing guidelines
• Ability to speak, read, and write English
• Good Oral and communication skills
• Experience with batch records

• Good Documentation Practices
• Report deviation and nonconformance experience

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

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Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the Internet, or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.