Spec , Quality Control

JOB DESCRIPTION

Responsibilities:

• Maintain Quality Reports.

• Perform chemical analysis on products to include raw materials, in-process, finish goods and stability product.

• Maintain and implement efforts in housekeeping, and safety programs.

• Must have awareness and respect of all company policies and safety rules.

• Maintenance of the Calibration program for laboratory equipment.

Requirements:

• Has an academic background and hands on laboratory training in the field of Chemistry.

• Understands and consistently follows multi-step documented procedures.

• Has hands on experience with USP/ISO/ASTM based chemical testing and performs all testing with strict adherence to the written laboratory work instructions.

• Understands the validation principles for chemical methods, develops and validates new chemical test methods, and prepares study reports as required.

• Maintains accurate and well-organized laboratory records, notebooks and/or worksheets.

• Use theoretical knowledge to interpret data and to trouble-shoot experiments.

• Maintain assigned aspects of the chemistry laboratory work to provide material and technical

support.

• With moderate or no supervision, apply comprehensive understanding of defined productivity goals and objectives.

• Maintain appropriate training/certification including GLP and GMP.

• Knowledge of FDA regulations for drugs and device desirable.

• Perform other assigned tasks on as needed basis.

• Must have awareness and respect of all company policies and safety rules.