Qa specialist
QA Investigations Specialist II
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 over three years of experience in technical writing and investigations within the sciences or lab industry. Responsibilities- 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 senior 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.
- 3+ years of experience in technical writing and investigations within sciences or lab industry.
- Experience with writing investigations.
- BS degree in Biology or other science field.
- Experience in a GMP environment is highly preferred.
- Experience from other highly regulated environments will be considered.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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