Job Title: Associate l & II, Quality Control
Job Number: 30203
Location: 215 First Street Cambridge, MA 02142
This individual will support quality control activities related to custom raw material manufacture conducted both internally and various CMO sites. This individual will assist in implementation of analytical methods including method transfers and method qualification/validations to support the in-process testing, release and stability of raw materials and monitoring, compiling, and reviewing data. The individual will also assist in managing quality events, data trending, review of quality documents originated at the testing laboratories as well as internally. All aspects of this position would involve working in a GMP compliant manner.
- Performing routine and non-routine analytical tests of custom raw material per cGMP for release and stability samples using HPLC, GC, KF and other general laboratory techniques
- Assist in writing and reviewing quality documents such as test methods, SOP, OOS/OOT and CAPA originated internally as well as at the vendor sites.
- Create and maintain clear and concise lab records and documentation
- Review HPLC, GC, KF and other general laboratory data generated per cGMP for release, retest, stability and reference material samples.
- Manage activities related to reference standard qualification and supply to external sites.
- Monitor, review and trending of intermediate stability data.
- Assist in writing and reviewing quality documents such as test methods, SOP, change controls, and investigations originated internally as well as at the vendor sites.
- Perform other related duties incidental to the work described
- MS with 1-2 years or BS with 2-4 years in Chemistry or related science field. With appropriate experience this requirement may be waived
- 2 years in a QC experience conducting release and/or stability studies in a cGMP environment is preferred
- Experience with laboratory equipment operation namely HPLC, GC, KF, pH and other QC related techniques
- Attention to details is a must
- Strong organizational skills
- Effective written and verbal communication skills
- Operate independently or as a part of a team, experience training individuals in a laboratory environment.
- Position may require some travel.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with company values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion