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GENERAL SUMMARY OF POSITION:

The QC Analyst I – Raw Materials is responsible the processing of all raw materials used in manufacturing processes according to standard operating procedures. 

May develop new raw material receipt processes.   Reviews data obtained for compliance to specifications and reports discrepancies.  May perform special projects on analytical and instrument problem solving.  Applies knowledge of current Good Manufacturing Practices and Good Laboratory Practices on a daily basis.

MAJOR RESPONSIBILITIES:

• Conducts receipt, inspection, quarantine, sampling & inspection on raw materials used in the manufacturing process of biological drug products, adhering to cGMP and cGLP regulations.
• Performs and processes the manufacturing of biological drug products through computerized platforms.
• Conducts chemical testing on raw materials, in-process, bulk and final vial samples as set forth in SOPs, adhering to cGMP and cGLP regulations.
• Compiles data of assays and raw material paperwork.
• Performs temperature monitoring of incubators, cold rooms, and freezers.
• Prepares and tests reagents used in assays and visual inspection materials as needed.
• Organizes and compiles data of data by statistical procedures.

• Takes initiative in solving technical problems that arise. 
• Troubleshoots assays and instruments problems with management.
• Assists in the qualification of new controls, standards and reagents.
• Maintains log books related to inventory and equipment.

• Performs daily, weekly and monthly calibrations and cleaning of various equipment.

• Ensure labs are clean and safe (in compliance with cGMP), and properly stocked.
• Makes detailed observations, analyzes data and interprets results. Performs other additional job related duties as required
• Performs sampling and visual inspection of labeled packaged products.

Performs sampling and visual inspection of filled product

MINIMUM QUALIFICATIONS:

• Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 0 to 2 years relevant experience

• Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
• Ability to adapt to a cGLP and cGMP regulated environment
• Ability to troubleshoot within scope of training
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
• Strong time management and organizational skills.  Demonstrated ability to multitask and consistently meet deadlines
• Ability to apply scientific principles to problem solving
• Possesses  well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills. Ability to communicate effectively with others
• Demonstrated initiative through past experience