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Job Description
Quality Operations:
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, and 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.
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:
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
About Strides Pharma Inc