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

• 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

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.