Rapidly expanding biopharmaceutical manufacturer is expanding their team and adding a QC Systems Specialist. The role will be located just under 50 minutes north of downtown Boston.
About the Role:
- Will initiate the equipment schedule for new facility.
- Perform review of equipment policies and procedures, gap analysis where required, and small-scale projects to complete departmental objectives.
- Execute the Historical Performance Review (HPR), a periodic review of equipment performance and use.
- Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
- Identify and recommend actions to take because of HPR findings.
- Ensures timely completion of instrument qualification/re-qualification activities through interactions with Validation and Calibration teams.
Qualifications:
- Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
- Excellent computer skills including knowledge of equipment data quality systems.
If interested please apply!