Quality Control Specialist II

Role Summary

The focus of the position is to manage investigations, respond to and drive audit commitments, change controls and assist with procedural improvements within associated timelines. This position will also perform routine release testing and environmental monitoring when needed.

Responsibilities

• Daily management of compliance commitments including driving the implementation of internal commitments, managing deviation investigations, and working cross functionally to support on time release of product.
• Coordinate, compile and present assay metric data for Quality Control.
• Coordinate, compile and write Environmental Monitoring trend reports.
• Manage quality project assignments through the Change Control and Risk Assessment process from evaluation of an initial proposal through approval, implementation, closure, and effectiveness review.
• Perform routine testing and environmental monitoring when needed.
• Assist with the progress of Trackwise deviations and CAPA management for applicable process deviations with the quality team and cross functional colleagues in Manufacturing and RA on investigations, root cause analysis and resolution.
• Perform RCA, analyst interviews, impact assessments, and data gathering for Trackwise events.
• Write and manage Laboratory Investigations; requesting assistance from internal teams when necessary.
• Communicate and interface with internal and external customers, including audit agencies when required.
• Proactively seeks to affect change to provide an inspection readiness state and reduce the number of observations identified during audits/inspections conducted.
• Assist with the development and implementation of corporate objectives for QC including but not limited to new electronic data systems like LIMS.

Qualifications

• HS Diploma, 6+ years’ industry experience in cGMP lab environment, or equivalent.
• AS/BS/MS degree in microbiology, molecular biology, biochemistry or a related discipline. AS, 4-5 years’ industry experience. BS, 3+ years’ industry experience. MS, 1+ years’ industry experience in cGMP lab environment, or equivalent.
• Ability to lift 40 lbs.
• Rotating holiday coverage, as well as weekend support as needed.
• May carry company issued cell phone for off-shift remote alarm coverage.
• Required to gown into classified manufacturing ISO 7 clean room areas.

Preferred Qualifications

• Ability to present technical data.
• Ability to lead and work independently on projects.
• Experience writing Standard Operating Procedures.
• Scientific technical writing ability including authoring and writing technical reports.
• Strong written and verbal communication skills.
• Experience with microbiological testing, biological assays, or environmental monitoring.