Commercial Quality Control Chemist

Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking a Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, the Commercial Quality Control Chemist will be responsible for performing routine and non-routine analytical testing in support of commercial pharmaceutical manufacturing, including facility testing, finished product release, stability programs, in-process control testing, raw material testing, and other quality control activities as assigned. The QC Chemist I executes analytical methods in accordance with approved procedures, cGMP requirements, and Good Documentation Practices (GDocP), ensuring accurate, reliable, and timely generation of analytical data. This position supports the Quality Control laboratory through effective execution of testing, proper documentation, equipment operation and maintenance, data review, and participation in laboratory investigations and continuous improvement initiatives.

Duties & Responsibilities

• Perform routine and non-routine analytical testing of commercial pharmaceutical products in accordance with approved analytical methods, specifications, SOPs, and laboratory procedures.
• Execute facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
• Operate applicable laboratory instrumentation and perform analytical techniques, including HPLC, GC, dissolution, UV-Vis, FTIR, and other technologies as qualified.
• Prepare samples, standards, reagents, and solutions in accordance with approved procedures.
• Accurately calculate, document, and report analytical results within established testing timelines.
• Adhere to cGMP laboratory standards, Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory requirements.
• Complete laboratory documentation ensuring accuracy and completeness.
• Review analytical data and supporting documentation for accuracy, completeness, and compliance with approved procedures.
• Maintain a clean, organized, and safe laboratory environment while following applicable safety and chemical hygiene procedures.
• Participate in investigations related to laboratory incidents, deviations, OOS, OOT, and other unexpected analytical results.
• Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs) as assigned.
• Support analytical method transfers and method verification activities as assigned.
• Participate in laboratory training programs and maintain required training and qualification records.