QC Technician I

Job Description

Job Summary:

• The QC Chemical Laboratory Technician assists QC analysts with support functions for routine analyses and documentation of any of the following: In-Process, Finished Product, Calibrations, Stability samples or projects within the QC Chemistry Laboratory, in a manner consistent with established standards.
• Supports internal development and/or manufacturing operations.

Duties and Responsibilities:

• Prepares test solutions including diluents and mobile phases.
• Collects dirty glassware and cleans glassware as the need arises.
• Performs daily instrument calibrations / verifications as the need arises.
• Maintains clear documentation in accordance with pharmaceutical industry standards.
• Co-ordinates and performs the collection of pharmaceutical waste from the laboratories, including dumping sample waste and removing/emptying solvent waste jugs, removing sharps containers, removing other pharmaceutical wastes.
• Cleans and maintains work areas and instrumentation.
• Tracks, receives and logs in solvents and other stock; orders and stocks the labs with supplies – including glassware; cleans and tidies general storage areas in the lab.
• Assists dissolution analysts with instrument set up and clean up.
• Co-ordinates or assists in the co-ordination of safety, audit or similar programs, including the weekly check of eye-wash stations.
• Ability to optimally communicate with personnel across multiple departments.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices and Safety guidelines.
• Maintains the vital compliance status required by company and facility standards.

Education and Experience:

• Typically requires no previous related experience.
• Work experience in a laboratory environment is preferred.
• Degree in physical science, preferably in Chemistry or Biology.

Knowledge, Skills and Abilities:

• Good knowledge and understanding of basic instrumental technologies and qualitative and quantitative chemical analyses.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Good problem-solving skills and logical approach to solving scientific problems.
• Follow all company policies, SOPs, cGMPs, work instructions, methods and analyst’s guidelines.
• Demonstrates efficiency by multitasking and scheduling time to meet required workload.
• Actively seek additional assignments when testing in primary area of responsibility is completed.
• Takes initiative and independently pursues training and/or learning opportunities to improve personal skills and share skills with other team members.
• Shown interpersonal and communication skills (both oral and written).
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
• Ability to work in a fast-paced environment.

Top Skills:

• PH Meter
• GXP Documentation
• Volumetric Glassware
• Laboratory Safety
• GXP Documentation

Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.
• Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of weights up to 50 pounds.
• Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time.
• Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
• Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.