Title: QC Associate II
Location: Research Triangle Park (RTP), NC
Duration: 6 Months Possible Extension
Job Summary:
- The Quality Control Biochemistry Associate II is responsible for contributing to key functional, tactical, strategic and operational aspects of the large molecule testing for Biochemistry group.
- This includes performing in-process, release testing, method transfer, validation testing and related activities associated with this testing.
- Associate II s responsibilities include, but are not limited to testing pH, Appearance, Osmolality, Protein Concentration (UV, RI, and SoloVPE).
- The Associate II should possess a fundamental understanding of the Quality Systems and apply it in their daily support functions.
- Additional responsibilities include ensuring adherence to all GLP/GMP requirements, interfacing with Quality and manufacturing as applicable.
- Supporting investigations impacting the QC department. The Associate II should be able to work effectively within the group, within Quality and across site. This requires solid and robust written and verbal communication skills.
Principal Accountabilities
Accountability Description
| Accountability Description | Percent of Time |
| 1. Performs in-process, release testing, method transfer and validation support activities/testing. Supports investigational activities including testing. | 85% |
| 2. Supports QC Biochemistry operations related to business and manufacturing schedules; support of process validation initiatives. | 10% |
| 3. Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results. | 5% |
| Total | 100% |
Minimum Education Requirements:
B.S. Degree (Science Preferred)
Minimum Experience Requirements:
2 years of relevant experience (M.S. degree) or 3 years of relevant experience (B.S. degree)