QA Associate I
Strides Pharma · Chestnut Ridge, NY, US ·
- Category
- QA
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