Position Summary:

The Quality Assurance (QA) Operations Sr. Specialist will be responsible for day-to-day support of GMP operations at the RTP CARsgen facility for clinical and commercial products. The team member will provide QA oversight of clinical trial drug production supporting raw material and product disposition. Additionally, this role is responsible for supporting department deliverables/metrics, supporting investigations/deviations, Change Controls, and CAPA’s associated with products/process occurring at the site. This position interacts cross-functionally with Manufacturing, Regulatory, Quality Control, Supply Chain and Technical Operations.

Responsibilities:

• QA Operations Sr. Specialist will be responsible for on-the-floor QA support for GMP operations, in-process batch record review, QA visual inspection, production batch record review, raw material disposition and support product disposition.
• Oversee line and production room line clearances.
• Support label issuance and reconciliation.
• Support GMP operations by ensuring aseptic techniques and good cleaning room behaviors are followed.
• Oversee and assist the deviation investigations and ensure on-time closure of the deviations.
• Provide QA support for the QC activities, including the review of QC testing records, SOPs and reports.
• Provide QA support for the Supply Chain activities, including the review of incoming materials, SOPs and reports.
• Create, revise, and implement quality assurance standard operation procedures and work instructions for the site when necessary.
• Conduct data analysis to support tracking of Key Quality Performance Indicators and generate the quality metrics monthly reports.
• Support internal and external audits.
• Supports continuous improvement efforts regarding Operations as it relates to Quality Management processes by identifying improvement opportunities and presenting solutions to the improvement opportunities.
• Perform all other duties as assigned per supervisor/management.

Qualifications:

• 8 years of experience in the clinical and/or commercial pharmaceutical / biopharmaceutical industry. Degree in Biology, Microbiology, Biochemistry, or other life sciences from an accredited university or college. Or a minimum of 3 years of experience in GMP with a Master of Science in Biology or similar.
• 6 years of direct experience in Quality Assurance / Quality Control (Preferred).
• Good knowledge of biologics cGMP manufacturing including ideally cell therapy and aseptic processing. Cell Therapy experienced (Preferred).
• Must be comfortable in a fast-paced environment with minimal direction and changing priorities.
• Strong interpersonal skills and ability to work collaboratively across functions.
• Growth oriented with a continuous improvement mindset, and passionate about working with others in GMP environments.
• Ability to communicate in a proactive and solution focused manner, including keeping management aware of potential issues.
• Goal oriented with the ability to troubleshoot and resolve problems