Quality Assurance Specialist I - CAPA Investigations

Andelyn Biosciences, Inc•Columbus, OH

About The Position

The Quality Assurance (QA) Specialist I - CAPA Investigations is an individual contributor role and provides compliance and quality improvement support to Andelyn. This role will work in conjunction with QA Management to support the quality management program and to ensure manufacturing operations are compliant with applicable regulations, policies, and procedures. The QA Specialist I will support the Investigations/CAPA team. This position will report to the QA Manager - Investigations to support the Investigations/CAPA team and will work closely with the Andelyn Operations staff.

Requirements

Must possess relevant four-year degree (B.S./B.A.) in a scientific discipline OR relevant Master’s degree
0–2 years of relevant experience (w/4 YR deg) OR relevant Master’s degree with 0 years of experience
Strong communication, organizational, and time management skills with the ability to manage assigned tasks and adjust as priorities change.
Proficient in Microsoft Office (PowerPoint, Excel, Word) including basic data interpretation and reporting.
Ability to work independently under routine supervision as well as collaboratively in a diverse and inclusive work environment.
Must possess a client-focused mindset in daily task.
Must possess the ability to handle confidential information and maintain confidentiality.

Nice To Haves

Academic, internship, or industry experience in biologics preferred
Experience in gene therapy preferred
Familiarity with a highly regulated cGMP environment preferred
Foundational knowledge of regulatory (FDA) requirements and basic understanding of aseptic processes preferred

Responsibilities

Participate as QA representation in continuous improvement committees or working groups and learn process improvement tools to support working groups
Assist with deviations, investigations, CAPAs, and other related controlled quality records.
Perform QA functions related to Operations to support the Investigations team, including supporting internal and regulatory audits.
Routinely identify quality issues and report them to senior QA staff and management.
Provide support to QA Management and senior team members for client and third-party audits.
Assist QA Management and senior investigators with identifying areas for quality improvement and gathering metrics to monitor progress toward quality objectives.
Exercise discretion, judgment, and personal responsibility.
Demonstrate a high level of integrity.
Maintain a positive attitude
Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
Attention to detail in all job functions
Performs duties following established policies, procedures, and techniques under general supervision, requiring foundational training or basic working knowledge related to the tasks performed.
Assist in solving, correcting, and preventing problems, and perform tasks assigned by leadership
Work toward specific measurable objectives requiring operational planning skills under general supervision.
Documentation of all activities performed according to SOPs and Good Documentation Practices (GDP).
Make routine decisions based on established procedures
Infrequent travel required
Minimal to moderate involvement in audits
Minimal to moderate involvement in customer relations
Supportive role in inspection outcomes.
Other duties as assigned

Benefits

Eligible day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
160 hours of Paid Time Off annually
11 Company Paid Holidays plus 2 floating holidays annually.
Company Paid Life Insurance
401(k) Match
Company Paid short and long-term disability.
4 weeks of Paid Parental Leave for birth and adoption
Adoption Assistance
Tuition Reimbursement and Student Loan Repayment Assistance
Company Paid LinkedIn Learning access.
Employee Assistance Programs
Flexible work options (role specific)