QC Analyst I

The QC Analyst I is responsible for sampling and inspecting various incoming materials including but not limited to raw materials active pharmaceutical ingredients, excipients, components, and processing aids. The QC Associate 1 interacts with multiple departments such as Quality Assurance, Manufacturing, Receiving and Supply Chain. This person is responsible for evaluating information and products and reporting any discrepancies or defects.

Responsibilities:

• Follow written procedures
• Review documentation such as CofAs, assign expiration and retest dates for incoming raw materials
• Coordinate the sampling of all incoming raw materials and components
• Collaborate with Supply Chain, Warehouse, Receiving, Quality Assurance, Operations and the testing laboratory in order to schedule activities
• Log samples into Laboratory Information Management System (LIMS), assign testing requirements and enter analytical results
• Verify raw material labeling such as part and lot numbers, Inspect containers for defects and damage
• Clean sampling, equipment and any associated sampling areas
• Operation of equipment such as glove-boxes, fume hoods, bio safety cabinets and balances
• Perform sampling for all raw materials, active ingredients, excipients, components, processing aids etc,
• Follow written procedures for sampling techniques and requirements
• Perform the visually inspection and dimensional testing of components
• Operation of equipment such as calipers, tape measure, gauge blocks and sight gauges
• Identify non-conforming materials at any point in the process
• Coordinate retain program
• Prepare and maintain retain samples for raw materials
• Receive and maintain finished product retain samples
• Plan, schedule and execute periodic retain inspections in compliance with written procedures for both raw materials and finished products
• Perform disposals of both raw materials and finished products when appropriate
• Author and review Standard Operating Procedures, technical reports, specifications, as required
• Train other colleagues in methods and procedures
• Assist in investigating any non-conformances or problems noted during the sampling/inspection process
• Use electronic document, inventory and maintenance systems, LIMS, SAP, Veeva, Microsoft Word, Microsoft Excel, Maximo

Qualifications:

• Bachelor's degree in a scientific discipline required
• A minimum of 1 year experience in a pharmaceutical or other regulated industry preferred
• Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts
• Ability to handle multiple projects with competing priorities
• Fundamental understanding of mathematics
• Intermediate skills in computer use with ability to learn and master new computer applications
• Self-directed and motivated, detail oriented, quality minded with strong organizational skills
• Effective oral and written communication skills When required, interact with internal and external auditors
• Understands paperwork review process
• Ability to follow written procedures and exhibit excellent documentation practices
• Ability to take on additional tasks, as required
Ability to lift up to 50lbs Work well independently or with a group

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