Quality Assurance Specialist II

*Contract to hire*

Shift is Tuesday – Friday 7:00 AM - 5:00 PM

The Specialist II will support Quality Assurance lot release and disposition activities including process observation, batch record review, and completion of lot release documentation. The Specialist II supports QA initiatives including, but not limited to, review of laboratory investigations, deviation investigations, method validations, change controls, and CAPAs. The successful candidate will be able to effectively communicate bi-directionally in a complex, changing, and fast-paced environment.

Essential Functions and Responsibilities

Quality Assurance Operational Support:

• Perform QA Operation activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.
• Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
• Perform real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives, escalating issues as required.
• Track and communicate standard work completion and hurdles.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Maintain a collaborative and professional relationship with CMOs.
• Release of raw materials and inventory.
• Prepare and organize release documentation for approvals.
• Support internal audits and regulatory inspections

Subject Matter Expertise:

• Act as a subject matter expert (SME) and train incoming staff.
• Support the efficient and timely review of laboratory investigations, deviation investigations, method validations, change controls, and CAPAs.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
• Experience with cell therapy products and cleanroom manufacturing.
• Experience with CAPAs and change controls
• Knowledge of cell culture testing

General:

• Ability to work effectively on multiple projects simultaneously with minimal supervision
• Excellent oral and written communication skills
• Must possess a high level of attention to detail
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
• Strong computer, organizational, and compliance Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint
• Must be comfortable in a fast-paced environment with changing priorities
• Support QA and Logistics activities for on-going projects.
• Assist with implementing GMP QA procedures
• Other duties as assigned.

Required Education, Skills, and Knowledge

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.
• At least 4 years demonstrating proficient GMP QA/QC experience
• Experience with deviations and laboratory investigations within an electronic QMS (i.e. MasterControl, Veeva).
• Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.
• Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality systems

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.