CTL Quality Assurance Associate I

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