QA Associate II
Stridespharmausa
- Ridge, New York, United States
- Ridge, New York, United States
About
QA Associate II Full Time Professional Chestnut Ridge, NY, US
4 days ago Requisition ID: 1166
Salary Range: $22.00 To $27.00 Hourly
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, and process validation and qualification activities. 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
Roles and Responsibilities
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
Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances
Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures
Actively participates in process validation and equipment qualification activities
May execute computer data entries in SAP, Leucine, LIMS, and department databases
Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes
Performs manufacturing/packaging stage reviews of batch records
Education & Experience
High school diploma or equivalent with 4-7 years’ relevant experience OR
AA/AS degree with 3-6 years’ relevant experience OR
BA/BS degree with 2 -5 years’ relevant experience
Related discipline and certification in assigned area a plus
Experience with statistical sampling methods a plus
Knowledge & 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
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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Languages
- English
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