QC Chemistry Technician

Pine PharmaceuticalsTonawanda, NY
$20

About The Position

The QC Chem Technician is responsible for general laboratory routine work and cleanliness. Providing support on sample submission and tracking. Conducting simple routine chemistry testing for raw material, stability and finished good products to ensure product compliance and providing laboratory support to hit product deadlines. Support the incoming quality control (IQC) workflow and processes and support IQC/QC Analysts with test preparations and general lab necessities.

Requirements

  • A Bachelor’s degree in an applicable scientific field
  • OR
  • An Associates degree in a scientific field with 1 year relevant experience preferred.
  • OR
  • May consider candidate with a high school diploma with minimum of 2 years relevant experience.
  • Experience in the use of analytical techniques.
  • Strong attention to detail with the ability to follow standard operating procedures.
  • Able to adapt and respond quickly in a fast-paced environment.
  • Able to communicate in a professional manner and interact with management, clients, and vendors on a routine basis.
  • Must possess good communication skills as well as computer skills (Word, Excel, Outlook, etc.).
  • Must be organized and flexible with an ability to handle multiple work assignments.
  • Experience with cGMP 21CFR 11/210/211/820 Quality systems preferred.
  • Experience with United States Pharmacopeia (USP), preferred but not necessary.

Nice To Haves

  • Knowledge of GMP is a plus.

Responsibilities

  • Produces routine analytical work in accordance with all applicable Standard Operating Procedures and approved analytical methods.
  • Performs safe sampling and inspection of active pharmaceutical ingredients, excipients and containers for In-House and Outside Laboratory Testing to support multiple facets of the company.
  • Conducts simple lab tests with some complex technical requirements such as pH, Identifications, color and clarity, physical appearance, USP testing, etc.
  • Follow good documentation practices per company standard operating procedures.
  • Practices Good Manufacturing Practices (GMP) in a pharmaceutical laboratory environment.
  • Reviews and verifies sampling, inspections and testing performed by peer analysts.
  • Perform weekly/monthly laboratory maintenance also performs general maintenance and calibration of laboratory equipment.
  • Use multiple level instrumentation in daily processes, including but not limited to FTIR, UV vis spectrophotometer, Karl Fisher units, balances, pH meters, etc.
  • Support Finished Goods and Stability sample flow and testing as needed.
  • Maintains safe and healthy working conditions in the assigned work area.
  • Recognizes nonconforming testing results and reports them promptly to IQC/QC management.
  • Works with other groups to ensure inspection timelines are met and reports routine status updates to IQC/QC.
  • Works as an effective team member to meet departmental objectives, sharing knowledge with the team members and across the laboratory.
  • Properly disposes of chemical waste in appropriate waste streams according to health, safety, and environmental practices.
  • Coordinates laboratory samples / paperwork shipment and entry into laboratory management system following standard operating procedures.
  • Assists with the filing of documents as needed.
  • Responsible for the efficient utilization of resources and supplies to reduce waste and achieve cost reduction.
  • May perform other duties as assigned.
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