Title:  Quality Lab Associate I, Chemistry

Perform routine functions of the Chemistry Laboratory.  Conducts physical inspections of components and printed materials, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability, in accordance with Standard Operating Procedures and Specifications. Additionally, the candidate samples raw materials and water. The duties also include LIMS lot login and data entry, equipment maintenance, glassware cleaning, and housekeeping.

Responsibilities

• Samples raw materials and water for laboratory testing and logs lots in LIMS, as assigned.
• Conducts critical chemical and physical testing, and routine inspections on incoming components, raw materials, initial, in-process, final products and stability samples, along with customer complaint and retain samples per cGMP, Company SOPs and Specifications. Works under minimum supervision.
• Performs duties in support of the day-to-day functions of the QC Chemistry Laboratory. This includes but not limited to, physical inspections, wet chemical analysis, instrumental analysis, (Conductivity meter, Osmometer, etc.) and other various laboratory methods.
• Use sophisticated laboratory instrumentation (HPLC, GC, FTIR, AA, UV/Vis, etc.) and computer systems to collect and record data.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner. Enter data in LIMS.
• Maintain data integrity and ensure compliance with company SOPs and specifications, USP, Ph.Eur., FDA, GLP, GDP and cGMP regulations.
• Investigate deviations and write exception documents.
• Perform laboratory housekeeping and glassware cleaning.
• Perform safety and documentation audits monthly. Maintains laboratory cleanliness as needed.
• Perform equipment maintenance and calibrations as required.

Qualifications 

• Bachelors Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework and 0-2 year’s experience.
• Experience with HPLC and GC is preferred.
• Ability to handle multiple tasks concurrently, and in a timely fashion
• Computer literate.
• Must be detail oriented, conscientious and have high reading comprehension skills.
• Must have basic understanding of laboratory instrumentation.
• Must be able to communicate effectively with supervisors and peers.
• Must be able to accommodate a flexible work schedule (weekends, shift, etc.) which may be required for business needs.
• Physical Demands
  • Ability to walk distances of 1-3 miles per day.
  • Good manual dexterity to repetitively manipulate syringes, vials, stoppers, etc.
  • Ability to lift up to 45 pounds.

What We Offer

• Clean climate-controlled working environment (Operator roles at the top)
• 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

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms