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