POSITION SUMMARY

The Quality Associate I, Operations is responsible for actively participating in "on the floor" Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.

ESSENTIAL FUNCTIONS

Quality Operations Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule. Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging. Follows internal processes related to controlled substances Performs GMP-related verifications such as line clearances, cleaning, room inspection, and materials. Collects and appropriately labels packaging retain samples, and submits to the archive storage. May execute computer data entries in CME, JDE, LIMS, and department databases Collects retain samples and performs sample evaluation for Annual Product Review May backup third party product review/release Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components or release testing Non-Conforming Events Responds to and escalates events identified during production to Quality Management Participates in investigations with the Rapid Response Team as needed Process Improvement Collaborates with Manufacturing and Quality partners to identify and implement improvements Compliance Conducts GMP walkthroughs of facilities Learns how to perform in-process audits to identify adherence to SOPs and BPR requirements Actively participates in training events, and maintains currency with assigned training requirements Safety Follows all procedures to ensure a safe and compliant work environment.

QUALIFICATIONS

Education & Experience High school diploma or equivalent with 2-4 years' relevant industry (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred) Knowledge & Skills Ability to communicate and work with teams Attention to detail Strong documentation skills Ability to read and interpret SOPs and function within the scope of procedures Proficiency with basic math skills and basic experience with computers and software applications required Ability to learn new processes and procedures Able to communicate effectively with other departments, management and operational personnel Customer/Stakeholder focused (understands impact of daily work to compliance and overall business) Proof-reading skills; ability to identify errors Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs) Experience with Enterprise Resource Planning (ERP) system is a bonus Ability to work overtime as needed, including occasional weekend shifts Physical Requirements Lift 15 lbs. Walk across plant/warehouse Wear appropriate gowning as required Ability to read for extended periods of time