Quality Control Analyst - Pharmaceutical, Phoenix, AZ
The Associate Analyst, QC Control Center is responsible for assisting with maintaining the daily operations of the QC Control Center. This position is responsible for receiving and distributing samples, standards and worksheets used for analysis of raw material and product samples. The Associate Analyst under guidance provides assistance with the Stability and Reserves Programs.
The incumbent assures individual compliance with FDA regulations, cGMP's and applicable department programs, including training, documentation, standard operating procedures, and policies and procedures.
This is a Monday - Friday position, 6 month temporary with possible extension.
Duties and Responsibilities:
- Provide customer service to impacted site departments.
- Receives samples for distribution QC Laboratories.
- Manages the accountability of samples.
- Issues documents for testing in the QC Laboratories.
- Files completed documents returned from the QC Laboratories.
- Assists with service contracts and purchase requests as needed.
- Reserve Program Involvement includes but not limited to:
- Delivery of samples/components to appropriate storage areas.
- QA Evaluation assistance
- Sample/Component destruction
- Stability Program Involvement includes but not limited to:
- Assist with Stability Pulls
- Receiving stability samples
- Stability sample destruction
- Maintain laboratory reagent, consumables, and standard inventories
- Ensure standard inventories are completed inventory maintained.
- Assist in the receipt of laboratory reagents and supplies.
- Performs other duties as assigned.
- High School Diploma or equivalent required.
- 3 years in a regulated industry required.
Required Competencies: Knowledge, Skills, and Abilities
- Basic PC skills
- Basic math skills
- Basic written and verbal communication skills
- Basic proficiency in Microsoft Word, Outlook, and Excel
- Basic cGMP documentation skills
- Strong attention to detail
- Basic knowledge of warehouse safety practices
- Ability to use basic hand tools
- Ability to use PPE effectively
- Ability to collaborate with peers on day-to-day tasks; cooperative and works well with a team
- Ability to communicate effectively with peers and department management
- Ability to accurately and completely understand and follow SOP, test method, and cGMP requirements; uses good judgment and follows procedures
- Basic knowledge of cGMP and OSHA; ability to deal appropriately with regulatory agencies
- Ability to work highly supervised; solicits direction from supervisor
- Demonstrates personal organizational skills
- Actively seeks opportunities to learn
- Ability to pass an initial full physical with annual monitoring
- This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
- The incumbent must be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
- The incumbent must analyze numerical values on a daily basis.
- The incumbent will be working in a warehouse setting up to 6 hours per day.
- The incumbent will occasionally be working around hazardous materials to include chemical agents up to 6 hours per day.
- The incumbent often works for extended periods alone, up to 8 hours per shift.
Questions? Contact Kevin at email@example.com or call at 623-688-2142
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