Job Title: Quality Specialist

Job Description

We are seeking a talented and highly motivated Quality Specialist responsible for executing the Quality System and associated support processes. You will interface directly with Manufacturing, Supply Chain, and Clinical Operations leadership teams to support and achieve quality and compliance goals. Your role will also involve providing input on key global QA/Compliance and business initiatives.

Responsibilities

• Execute GxP Quality systems including Documentation Management, training, and GxP audits.
• Support Regulatory and 3rd Party Audits and Inspections.
• Oversee GMP operations including quality review of batch records, analytical data, and lot disposition activities of drug product, packaged, and labeled drug products.
• Lead investigations for any non-conformances during GxP activities.
• Oversee GcP compliance with respect to clinical site and CRO audits.
• Ensure compliance with applicable internal and external regulations, standards, policies, and procedures related to quality and regulatory status and performance.
• Maintain a compliant quality system that adheres to regulatory expectations internally and with respect to oversight of the company’s suppliers.
• Work with CMC, non-clinical, clinical, regulatory, and other teams to ensure document/data integrity for regulatory submission and inspections.
• Interface directly with Research, Development, and Clinical teams to actively influence and participate in quality compliance initiatives.

Essential Skills

• GxP auditing and risk-based strategy implementation.
• Experience with Quality Management and product release processes.
• Strong time management skills.
• Experience in overseeing GMP operations and compliance.
• Ability to lead investigations and ensure GcP compliance.
• Strong organizational and interpersonal skills.
• Proven ability to work in a collaborative team environment across multiple technical functions.

Additional Skills & Qualifications

• Minimum of 3 years of experience within the Quality and/or Compliance area.
• Knowledge of US and Worldwide GxP regulations.
• Experience with regulatory compliance inspections.
• Compliance/QA experience in biopharmaceuticals.
• Experience with electronic GxP systems approaches and implementation.
• B.S. in Biology, Chemistry, Engineering, or related fields preferred.

Work Environment

This position involves working in both an office and cleanroom environment within a fast-paced, start-up mentality cell therapy company. The role requires adaptability and the ability to wear many hats, contributing to a growing team.

Job Type & Location

This is a Contract position based out of Frederick, Maryland.

Pay and Benefits

The pay range for this position is $34.00 - $41.00/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 onsite position in Frederick,MD.

Application Deadline

This position is anticipated to close on Sep 6, 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 : $34 - $41