Quality Documentation Associate

Company Description

Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,400 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.

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.

1. Responsible for DHR (batch history) reviews and COC/COA approval.
2. Conduct investigations for Nonconformance’s and CAPA’s.
3. Enter NCR’s non-conformances into MES.
4. Perform cycle counts for finished goods and raw material.
5. Ensure that all audits are performed as scheduled.
6. Review reports and files for discrepancies
7. Maintain and store Quality Assurance and Quality Control documentation.
8. Provide training to users of the Nonconformance module in MES.
9. Departmental data entry.

Qualifications

1. High School Diploma.
2. A minimum of 1 year experience in a FDA regulated industry.  Medical Device or Pharmaceutical preferred.
3. Working knowledge of ISO 13485 and 21CFR820.
4. Internal audit experience preferred.
5. Associate Degree in technical or quality discipline preferred.
6. Knowledge of Good Manufacturing Practice,  Good documentation Practices, or Good Laboratory Practice experience
7. Proficient with standard office computer applications (email, calendar, word processing, spreadsheets, presentations; e.g. MS Office). 
8. Excellent people skills, including verbal and written communications, at all business and customer levels.
9. Effective communication with all document owner.

Additional Information

All your information will be kept confidential according to EEO guidelines.