QC Laboratory Chemist

Position Title: QC Laboratory Chemist - Healthcare Products 

location: Dallas, Texas

JOB DESCRIPTION: (quick summary of the role)

The Quality Control Laboratory Chemist will be responsible for sampling and testing raw materials, products in mid-production, and finished products. On a daily basis, you will evaluate raw materials that arrive to ensure they meet quality standards and project specifications. While products are in production, you will select random samples to ensure quality is maintained throughout the process. Once the finished products come off the floor, you will examine them and document any problems you discover before they head to distribution. You will also be responsible for cleaning and storing tools and equipment and documenting all of your tests properly.

QUALITY CONTROL CHEMIST DUTIES AND RESPONSIBILITIES

• Perform analysis with a practical understanding of the test procedure and instrument   operation;
• Work under direction provided by supervisor and Other duties as assigned;
• Maintain required level of training needed to perform a GMP task;
• Organize work schedule to complete assigned tasks efficiently and on schedule;
• Perform laboratory analysis right first time, contemporaneous documentation, analyze 

and document the results;

• Maintain accurate record of analysis and perform documentation to company standards;
• Notify manager immediately of nonconforming data or unexpected occurrences;
• Prepare test solutions, volumetric solutions, and samples used in analysis;
• Other duties as assigned by management as needed;
• Perform LC/MS for compound characterization and identification with supervision;
• Support regulatory inspections and audits;
• Support of various stability study protocols and execution of study tests;
• Preparation of laboratory reagents and samples; operation of instruments; data analysis; preparation of analytical reports; notebook documentation;
• Lift up to 30 pounds on occasion;
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.

qualifications: (Required Education & Skill sets:)

Bachelor’s degree in Chemistry or higher from an accredited institution

Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements;

5-8 years of relevant laboratory experience, with 4-5 years of QC specific experience;

Working knowledge of statistics along with advanced software expertise, such as JMP or LIMS, is optimal;

• Demonstrated ability to lead technical teams;
• Demonstrate strong oral and written communication skills;
• Experienced in leading technical lab investigations;
• Familiar with Inhalation or Transdermal products and test methods;
• Familiar with Raw Material testing, Global compendia and ICH;
• Basic understanding of GMP/GLP;
• Testing experience within the pharmaceutical industry.