QA Associate I

Job Description

Job Description

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