Quality Lab Associate II, Chemistry

OVERVIEW

Conduct biochemical, chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods, and stability programs.

 

RESPONSIBILITES 

• Conduct critical biochemical, chemical and physical analyses on raw materials, initial, in-process, final products, and stability programs. 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 assays requiring precise analytical skills and understanding of biochemical and chemistry principles. Perform calibrations and maintenance as required.
• Perform advanced biochemical and chemical assays requiring precise analytical skills and understanding of biochemical 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, USP/Ph Eur, FDA, GDP 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 (cGMP, safety, housekeeping, etc.). Make necessary corrections as needed.  
• Responsible for maintaining laboratory housekeeping, cleanliness of laboratory equipment and work benches, and other general lab responsibilities as assigned by supervisor.

 

QUALIFICATIONS

 

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. Must be able to consistently demonstrate self-motivation and the ability to think independently. Maybe required to work flexible hours and overtime on short notice.

 

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 year’s experience.

 

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave