QA Generalist

Job Title : QA Generalist

Join our Quality & Compliance team as a QA Generalist, focusing on ensuring high-quality standards within the biotechnology industry. You will play a crucial role in maintaining compliance with regulatory standards and collaborating with cross-functional teams to uphold product integrity and safety. This position requires biotechnology technical transfer experience, particularly in cell therapy, along with process characterization and batch record review experience.

Responsibilities

• Perform batch record review and release in support of US and ex-US clinical trials.
• Investigate and address product quality issues, including deviations, OOS results, and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization.
• Provide Quality support to CMC throughout the product lifecycle.
• Review and approve technical transfer documents including protocols, reports, master batch records, and test methods.
• Implement, maintain, and improve the Quality Management System (QMS) in accordance with internal policies, procedures, regulatory requirements, and industry standards.
• Assist in the creation and maintenance of SOPs, policies, and associated documents.
• Compile metrics for internal and external operations.
• Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls.
• Ensure that all documentation is accurate, complete, and compliant with internal policies, procedures, and regulatory standards.
• Assist in preparing for internal and external audits.
• Support in the execution of internal audits to ensure compliance with regulatory standards.
• Address and resolve audit findings, ensuring corrective actions are implemented.
• Assist in the preparation of regulatory filings and submissions.

Essential Skills

Additional Skills & Qualifications

Work Environment

Enjoy the flexibility of remote work with first shift hours. You will work closely with a team of two others within the Quality Management System, along with a manager and director. Our company is committed to providing a supportive environment with opportunities for continuous self-development. Benefit from accrued PTO, holiday pay, and accrued sick pay as part of our comprehensive benefits package.

Job Type & Location

This is a Contract to Hire position based out of Philadelphia, Pennsylvania.

Job Type & Location

This is a Contract to Hire position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $35.00 - $50.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following :

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Nov 20, 2025.