QA Associate I
6AM City, LLC
- New York, New York, United States
- New York, New York, United States
Über
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/or 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 for 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 BR 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
Education High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)
Knowledge
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
Skills & Abilities
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) systems is a bonus
Ability to work overtime as needed, including occasional weekend shifts
This position is a 1st shift role. However, the ability to work full-time 2nd shift hours is a bonus
Physical Requirements
Lift 15 lbs.
Walk across plant/warehouse
Wear appropriate gowning as required
Ability to read and use a computer for extended periods of time
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Sprachkenntnisse
- English
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