Quality - Quality Records Specialist

Purpose And Scope Of Position:

• This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs.
• This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles.

Required Competencies: Knowledge, Skills, And Abilities:

• Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
• Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
• Strong organizational skills, including ability to follow assignments through to completion.
• Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
• Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
• Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
• Must be able to routinely recognize quality issues and assess risk.
• Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
• Develop, manage, & present CTL metrics, and associated corrective action plans to management
• Strong knowledge of problem-solving methods used to perform Root Cause Analysis
• Support CTL GMP audits and regulatory inspections, as required
• Support continuous improvement projects related to Quality oversight of CTLs.
• Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
• Perform all other duties as assigned by Management.

Education and Experience:

• Requires bachelors degree in Science or related discipline.
• Minimum 3-5 years of experience working in a regulated GxP environment.

Duties And Responsibilities:

• Initiation, Facilitation, and Track quality records from our external partners.
• Responds to challenges and additional workload in an efficient, professional, and timely manner.
• Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
• Strong writing and presenting skills.
• Other responsibilities as assigned by management
• Proficiency in Microsoft Word, Excel, PowerPoint, Share point, Smart sheets management tools.
• Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).

Working Conditions (Us Only):

• Sitting or Standing at a computer terminal for an extended period.
• Work in a conference room /meeting environment for moderate periods of time.
• Regular, predictable attendance is required.
• Flexibility with schedule(weekends, holidays, extended hours) as business demands dictate.
• Moderate noise i.e., business office with computers, phone, and printers.