Quality Specialist II

We are looking to add a Quality Specialist II to the Investigations team with a large Gene Therapy company in the area! This role will primarily be handling technical writing duties as it relates to Investigations and Corrective and Preventative Actions (CAPAs) for the the Quality Laboratory.

This is a hybrid position where you will be in office at least 3 days per week, but will have some flexibility to work from home 2 days per week as applicable. This position does not involve lab or bench work - rather it will solely be more of a desk position that works in conjunction with the quality lab.

An ideal candidate will have at least 3 years of experience in quality in the scientific field, and must have experience with writing investigations and CAPAs. Candidates must also have worked in a highly regulated environment.

Job Description

Join our quality team to oversee Investigations and Corrective and Preventative Actions (CAPAs). You will be responsible for drafting investigations and CAPAs for any quality-related issues. We are seeking candidates with at least three years of experience in writing investigations within a heavily regulated environment for the sciences/laboratory fields.

• Reviewing escalations of quality concerns.
• Perform some technical writing for investigations and CAPAs.
• Assist with all other quality documentation as needed.
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
• Ensure all product samples are properly labeled and document all aspects of sample allocation and transition in the respective format and systems.
• Maintain full accountability for product allocation across sample requirements and storage conditions.
• Evaluate processes associated with sample management to identify gaps and implement improvements.
• Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs).
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Perform tasks according to established policies, procedures, and techniques, requiring training, common experience, or working knowledge.
• Work under the close supervision of staff and leadership.
• Function effectively in a diverse and collaborative team environment, utilizing clear communication to achieve high productivity.
• Document all activities performed according to GMP, cGMP, GLP, QC standards, clean room protocols, and technical writing guidelines.

Qualifications

• Must have a Bachelors Degree in a scientific field
• Must have experience writing investigations and/or CAPAs.
• Must have experience in a highly regulated environment (GMP preferred, but would also be open to GLP, FDA, etc.)
• Must be located in Columbus, OH and interview in person

INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT 614. 339. 4783 TO SET UP A PHONE INTERVIEW!