Quality Documentation Associate

Company Description

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 87,500 sq. ft. production facility with 200 employees. 

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.