CTL Quality Assurance Associate I

The CTL Quality Assurance (QA) Associate I is a core member of the CTL QA team and is responsible for quality assurance and improvement activities in the Cellular Therapy Laboratory. The quality division manages quality assurance activities to ensure that systems are safe, effective, appropriate and compliant with applicable regulations and standards. The quality division also oversees quality control activities, which involves the qualification, receipt and storage of materials, oversight of environmental monitoring activities and analysis and analytical testing of cellular therapy products intended for clinical use. Candidates with experience in biopharmaceutical, pharmaceutical, cellular therapy, stem cell or clinical laboratory environments, as well as knowledge of the FDA's Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) or Foundation for the Accreditation of Cellular Therapy (FACT) product standards are encouraged to apply.

Minimum Education

Associate's Degree Biology or a related discipline. (Required)

Bachelor's Degree Biology or a related discipline. (Preferred)

Minimum Work Experience

1 year Work experience in a cGMP environment or clinical laboratory. (Preferred)

Required Skills/Knowledge

Knowledge of cGMP and current FDA policies related to biotech products and sterile drug manufacturing.

Functional Accountabilities

Responsible Conduct of Research

Consistently demonstrates adherence to the standards for the responsible conduct of research.

Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.

Uses research funds and resources appropriately.

Maintains confidentiality of data as required.

Meets all annual job-related training and compliance requirements.

Job Functions

Actively contributes to all Quality Systems such as investigations, change control, out-of-specifications, CAPA, raw materials and risk management.

Leads controlled document systems, including drafting, revising, maintaining and updating SOPs.

Leads continuous improvement initiatives across all CTL functions.

Leads auditing and investigation activities, performs root-cause analyses and helps to develop corrective and preventative action plans.

Provides support during regulatory inspections and client audits.

Independently manages facility maintenance to ensure an inspection-ready state.

Communicates effectively with co-workers, management and clients.

Collaborates with QC specialist and Lab Manager to ensure equipment qualification have been completed; preventive maintenance and calibration performed prior to due date.

Manages, monitors and tracks quality incidents and assists with QA investigations.

Adheres to all applicable cGMP guidelines, Children’s National and departmental policies and CTL SOPs.

Completes additional duties as required.

Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

Demonstrate collaborative and respectful behavior

Partner with all team members to achieve goals

Receptive to others’ ideas and opinions

Performance Improvement/Problem-solving

Contribute to a positive work environment

Demonstrate flexibility and willingness to change

Identify opportunities to improve clinical and administrative processes

Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

Use resources efficiently

Search for less costly ways of doing things

Safety

Speak up when team members appear to exhibit unsafe behavior or performance

Continuously validate and verify information needed for decision making or documentation

Stop in the face of uncertainty and takes time to resolve the situation

Demonstrate accurate, clear and timely verbal and written communication

Actively promote safety for patients, families, visitors and co-workers

Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance