Job Title: Quality Specialist
Job Description

We are seeking a talented and highly motivated Quality Specialist to join our team. The successful candidate will be responsible for executing the Quality System and associated support processes. This role involves interfacing directly with Manufacturing, Supply Chain, and Clinical Operations leadership teams to support and achieve Quality and Compliance goals. You will provide input on key global QA/Compliance and business initiatives and engage in GxP auditing, Quality Management implementation, product release processes, and training and documentation management. Additionally, you will review various regulatory documents and ensure compliance with applicable regulations.

ResponsibilitiesExecute 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.Provide oversight of clinical trial execution.Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes, and products, including GMP and GCP.Maintain a compliant quality system that adheres to regulatory expectations both internally and with respect to the oversight of the company’s suppliers.Work with CMC, non-clinical, clinical, regulatory, etc., as an active cross-functional team member to ensure appropriate 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 from a tactical GxP compliance perspective.Essential SkillsMinimum of 3 years of experience with increasing levels of responsibility within the Quality and/or Compliance area.Knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.Compliance/QA experience in biopharmaceutical.Extensive experience with electronic GxP systems approaches and implementation of such systems.Proven ability to work in a collaborative team environment across multiple technical functions.Ability to effectively interact with global functional areas (GxP), manufacturing sites (GMP), and third-party vendors.Strong organizational skills.Excellent interpersonal skills including listening, writing, negotiation, facilitation, attention to detail, and presentation skills.Additional Skills & QualificationsB.S. in Biology, Chemistry, Engineering, or related fields preferred.Work Environment

This position operates in both office and cleanroom environments. The role involves working in a fast-paced, growing cell therapy company where you will wear many hats and need to adapt quickly to changing situations.

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 Feb 10, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.