Quality Associate, Stability

Coordinate planning, testing, and reporting of stability analysis. Ensures all stability testing is completed in the required time frame in a quality manner and that all resulting data is reported as required. Includes coordination of testing between multiple departments as well as outside contract testing and storage relationships to achieve tasks. Includes coordination of storage and transport of samples. Includes management of related data systems.

Essential Duties & Responsibilities

• Assist in stability lot selection and management.
• Coordinate stability planning and execution.
• Coordinate testing activity to ensure timely completion of stability commitments.
• Support investigations into unexpected events related to stability (out of specification, out of trend, etc).
• Coordinate required reporting of stability testing results.
• Oversee storage transport of stability samples.
• Supervise stability data system management.
• Change control activity for documents and processes related to stability activity.
• Training and leadership for analysts performing stability and LIMS data functions.
• Generation of reports related to stability, for routine management and regulatory purposes.
• Perform other related duties as assigned or required.

Knowledge & Skills

• Familiarity with Quality Control Laboratory testing in a pharmaceutical environment. Majority is chemical testing, though some biological testing is also involved.
• Familiarity with compendial stability storage and testing requirements.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s in chemistry (preferred), or similar science or technical field.
• At least 1-2 years of recent pharmaceutical, medical device or regulated GMP experience is required with a thorough knowledge of various software programs such as MS Office, statistical applications, etc.
• Experience in investigation and management of out of specification and/or deviation events related to laboratory testing.
• Experience with GMP change management and document change processes.
• Experience with laboratory information management systems (LIMS, e.g., LabWare).

Work Environment

• Office environment with floor support as required for project execution as well as laboratory environment.
• Ability to lift up to 50 pounds, as related to shipping, storage, or transport of stability sample cases.
• Typically requires travel less than 5% of the time