Quality Lab Associate II

Job Description

Job Summary:

• Conduct biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.

Duties and Responsibilities:

• This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
• The incumbent will perform other duties assigned.
• Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
• Work under minimum supervision.
• Serve as Mentor to Quality Laboratory Associate (QLA) I positions.
• Provide training and work direction for QLA I positions as required.
• Perform review of test data, which includes overall documentation practices.
• Perform release functions in LIMS or other computerized systems.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data.
• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Investigate deviations and write exception documents.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required.
• Audit and update, as required, plant SOPs.
• Perform equipment maintenance and calibrations as required.

Education and/or Experience: 

• Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.

Knowledge, Skills, and/or Abilities:

• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills, basic knowledge of statistical method.
• Strong technical problem solving skills.
• Ability to handle multiple tasks concurrently, and in a timely fashion. Computer literate.
• Must be able to communicate effectively with supervisors and peers.
• Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.