Quality Control

Job Overview

US Specialty Formulations is a rapidly growing pharmaceutical manufacturer in the Lehigh Valley, PA. We provide end-to-end, boutique formulation and manufacturing services—from method analysis to CGMP production—to help innovators bring their products to market. We are on a mission to deliver high-quality pharmaceutical solutions that make a tangible difference in people's lives.

We are seeking a highly motivated and detail-oriented QC Lab Technician to join our dynamic laboratory team. In this vital role, you will be responsible for performing QC lab analysis of in process samples and finished products in a CGMP setting, present results to quality assurance personnel in a manner that is agreeable with ISO 9001 and USSF quality standards. Additional duties include stability testing as required. In the performance of your duties you will utilize a variety of modern analytical laboratory techniques and equipment.

The QC Lab technician reports directly to the QC Lab Manager and will assist the QC Lab Manager with routine in-process and release testing, ongoing stability testing, and calibration and maintenance of analytical laboratory equipment in a CGMP environment.

Duties

• Responsible for daily calibrations of all lab equipment to ensure equipment is acceptable for use
• Work independently, as well as in a team, to accomplish designated analytical testing tasks, and support production operators in their in-process testing,
• Clearly communicate with QC Lab Manager of any issues that arise and any details surrounding the issues so they may be handled and rectified in a timely manner
• Analyze in-process, release, and stability samples per established SOPs, utilizing instrumentation and scientific techniques to do so
• Become familiar and utilize statistical process control packages.
• Participate in ongoing training on laboratory techniques, safety protocols, and regulatory updates to stay current with industry best practices.

Experience

• Candidate must be able to maintain meticulous lab note documentation and attention to detail.
• Bachelor's degree in chemistry, or related field of study, or higher
• Able to comply with FDA, ICH, and ISO 9001 guidelines
• Experience in a cGMP pharmaceutical setting, or in a quality control laboratory setting
• Experience in wet chemistry techniques, HPLC, UV-Vis, and proficiency in other various instrumentation techniques
• Experience working in clinical or research laboratories involving animal physiology or veterinary terminology is a plus.
• Knowledge of laboratory safety protocols including proper handling of biological materials and hazardous chemicals.
• Excellent organizational skills coupled with the ability to follow detailed instructions precisely while managing multiple tasks efficiently.

Pay: $ $33.65 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Life insurance
• Paid time off

Work Location: In person