QA Product Release Coordinator
Quality Assurance | Santa Ana, CA
We are hiring for a QA Product Release Coordinator. The QA Product Release Coordinator will ensure the quality of the product by performing reviews of batch folder documentation in order to release the product. Creates and signs off all Certificates of Analysis. Responsible for return goods authorization product verification.
- Creates and maintains a database for Certificate of Analysis
- Review and process Return Good Authorizations
- Inspect the labeling and storage conditions of product
- Maintain the non-conforming material log, files, and database
- Assist in the preparation of all controlled documents (generating DCRs as needed)
- Reviews and improves processes as needed (provides training as needed)
- Maintains Device History Records files and database
- Performs internal audits as the needed
- Assist Document Control department as needed
- Collaborates with other departments to meet customer requests
- Lot folder scanning
- Two years of college in a science discipline is preferred
- A minimum of two (2) years of Quality Assurance in a medical device manufacturer or equivalent
- Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook
- Computer skills
- 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 and read English
- Good oral and written communication skill
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- While performing the duties of this job, the employee is frequently required to walk throughout the organization, sit, and review documents. Specific vision abilities required by this job include close vision and depth perception.
- Occasionally lifts up to 25 pounds
The work environment characteristics are those typical of a busy office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- The noise level in the work environment is that of a busy operations office with telephones, computers, and printers operating and with frequent people interruptions.
For California, the base salary range for this position is $59,000 to $94,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
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.
In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.
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.