QC Specialist II

Key Responsibilities

• Lead method transfers to support accelerated timelines for early clinical pipelines and internal product lines partnering with crossfunctional teams across Analytical Development site QC and external sites as needed.
• Perform routine equipment audits and system backups to ensure data integrity and system availability.
• Serve as System Administrator managing user access security and permissions for GMP laboratory systems.
• Collaborate with crossfunctional partners (Facilities Engineering IT) on the maintenance qualification and operation of QC laboratory equipment and systems.
• Act as a QC representative for specialized areas during sitelevel meetings and initiatives.
• Support and participate in internal external and regulatory inspections including preparation and direct inspection support.
• Resolve data discrepancies and missing information to support continuous quality improvement.
• Develop revise review and maintain SOPs qualification/validation protocols and technical reports.
• Monitor GMP laboratory systems to ensure compliance with documented policies procedures and regulatory requirements.
• Provide onthejob training and daytoday technical guidance to QC Lab Services staff under appropriate supervision.
• Perform QC sample receiving processing storage distribution and disposal in compliance with GMP requirements.
• Gather quality metrics and perform trend analysis to identify opportunities for improvement.
• Support adhoc projects and additional duties as assigned.
• Conduct and support OOS OOT investigations Deviation investigations CAPAs and Change Controls related to QC equipment and system management.
• Serve as Point of Contact (POC) for internal and external inspections related to QC equipment and systems.
• Work independently with minimal supervision; proactively identify troubleshoot and communicate issues to stakeholders.
• Use strong verbal and interpersonal communication skills to provide technical insight and achieve assigned objectives.
• Maintain a strong commitment to lab safety supporting a goal of zero OSHA recordable incidents.
• Work flexible hours across a sevenday workweek including overtime weekends or holidays as operational needs require.
• Perform physical activities including lifting up to 25 lbs and working with dry ice and LN₂ freezers.
• Delegate responsibilities to qualified deputies as appropriate.

Basic Qualifications

• Bachelors degree with at least 4 years or Masters degree with at least 2 years of handson laboratory experience in a biotech or biopharmaceutical setting.
• Experience working in a GMP or regulated environment.
• Ability to work independently and manage multiple projects simultaneously.
• Strong oral and written communication skills and demonstrated interpersonal effectiveness.

Preferred Qualifications

• Handson experience with biological and biochemical analytical methods including pH osmolality conductivity visual inspection and protein assays.
• Experience with ELISA qPCR ddPCR and flow cytometry (e.g. FACS Canto CytoFlex).
• Experience performing safety and microbiological assays including mycoplasma and endotoxin testing.
• Experience supporting QC equipment qualification validation and system administration in GMP laboratories.
• Familiarity with quality systems including Deviation CAPA Change Control OOS and OOT investigations.
• Strong attention to detail with a continuous improvement mindset.