QC Technician I

Duration: 10 Months+

Summary:

Responsible for performing sampling, routine and specialized testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Responsible for subcontract sample preparation, shipment, and receipt of associated data.

Description:

• Performs sampling of raw materials per approved procedures and specifications.
• Performs routine and specialized raw material testing according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
• Communicates with subcontract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing.
• Performs project related tasks as assigned with general instructions.
• Initiates and assists with OOS/deviation investigations.
• Writes and revises Standard Operating Procedures (SOPs).
• Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies.
• Maintains compliance with all required training.
• Trains other analysts on basic procedures.
• Runs analytical method transfer and qualification/validation experiments per approved protocols and with general instruction.
• Performs other duties as assigned.

Technical Skills:

• Prior experience with raw material testing such as wet ID, spectroscopy, titration, pH, osmolality, and/or conductivity
• Knowledge of basic and specialized lab equipment.
• Knowledge
• Demonstrates a solid understanding of cGMP principles. Able to identify breach of cGMP principles. Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation.
• Understanding of basic laboratory equipment and aseptic technique a plus.

Computer Skills

• Proficient in the use of spreadsheets, databases, and word processing software.
• Prior experience with SAP and TrackWise a plus

Communication:

• Writing is typically free of punctuation, spelling and grammatical errors.
• Provides timely, clear, and accurate updates without being prompted.
• Records test results and maintains raw data and accurate laboratory records.

Education:

• Bachelor's Degree in Scientific Discipline required.

Shift: Day