Quality Documentation Associate
Quality Documentation Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Provide administrative support to the Quality Assurance and Quality Control in order to proactively manage the Company Quality System Standards and Processes. Responsibilities include but not limited to clerical duties related to technical documentation of procedures and practices and proper upkeep of technical documents and systems.
- Responsible for DHR (batch history) reviews and COC/COA approval.
- Conduct investigations for Nonconformances and CAPAs.
- Enter NCRs nonconformances into MES.
- Perform cycle counts for finished goods and raw material.
- Ensure that all audits are performed as scheduled.
- Review reports and files for discrepancies
- Maintain and store Quality Assurance and Quality Control documentation.
- Provide training to users of the Nonconformance module in MES.
- Departmental data entry.
Qualifications :
- High School Diploma.
- A minimum of 1 year experience in a FDA regulated industry. Medical Device or Pharmaceutical preferred.
- Working knowledge of ISO 13485 and 21CFR820.
- Internal audit experience preferred.
- Associate Degree in technical or quality discipline preferred.
- Knowledge of Good Manufacturing Practice Good documentation Practices or Good Laboratory Practice experience
- Proficient with standard office computer applications (email calendar word processing spreadsheets presentations; e.g. MS Office).
- Excellent people skills including verbal and written communications at all business and customer levels.
- Effective communication with all document owner.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
