Quality Assurance Specialist

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

• Extensive knowledge of GMP, GCP ICH, and US/EU/UK regulations.
• Experience in cell and gene therapy.
• Experience supporting product technical transfer activities and comparability studies.
• Significant experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control, or Quality Engineering position.
• Demonstrated knowledge of Quality Management Systems, preferably electronic systems.
• Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a related field.
• Minimum of 4 years’ experience in biopharmaceutical operations, technical operations, and/or quality operations, with 2 years hands-on experience in Quality function supporting clinical or commercial lifecycle management.
• Experience with audit processes, document control, and Quality Management Systems: deviations, change control management, and CAPAs.

Additional Skills & Qualifications

• Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships.
• Effective presentation and writing skills.
• Ability to provide clear, pragmatic direction and advice regarding compliance issues.
• Must be highly organized and able to work collaboratively with a team.
• Experience in a startup early phase-late phase setting is highly desirable.

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.

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:

• 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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $35 - $50