Quality Control Scientist I​/II

Responsibilities

• Maintain and perform daily operations in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
• Write and work with other QC Staff and other departments in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
• Maintain and perform regular verification of the QC equipment for GMP compliance in coordination with the QC Director/Supervisor
• Implement and maintain GMP procedures such as following SOPs, Standard Testing Procedures (STPs), written procedures, and maintaining proper documentation as necessary for Quality Control
• Test, review, and release raw material used in the manufacturing facility for GMP
• Perform analytical analysis and review data for completeness and accuracy
• Receive, test, and release final product peptide manufactured at Bachem
• Test and release in‑process control samples used in the manufacturing facility for GMP
• Maintain a cGMP quality level of work for the QC operations to include training, documentation, and procedural work
• Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
• Write standard operating procedures, standard test procedures, and other related GMP documentation
• Perform QC analysis to include HPLC, UPLC, water, mass spectrometry, UV, GC, melting point, optical rotation, TLC, and misc. wet chemistry lab work and other related analytical equipment used for quality control of the GMP facility
• Calibrate and validate these methods when necessary
• Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing, and QC release
• Investigate any deviation or out‑of‑specification as necessary related to QC work performed as instructed by the supervisor
• Execute validations as necessary to include QC analytical methods performed, and other validations to support the quality of the manufacturing facility
• Follow safety guidelines for handling, disposal, and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
• Support validation and stability as necessary to include analytical work, documentation, and quality GMP procedures

• Bachelor’s degree in chemistry or related field
• Master’s degree in chemistry or related field (preferred)
• Minimum of 3 years’ experience in GMP pharma/biotech facility
• Experience with equipment maintenance programs
• Experience with the use of analytical techniques / instruments, including GC, HPLC/UPLC, and UV‑Spectrophotometer
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and Power Point
• Ability to effectively organize, multitask, and work in a fast‑paced, deadline‑driven work environment
• Ability to communicate in a proactive and solution‑focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment
• Ability to review Certificate of Analysis for reagents for the creation of specification documents
• Organization skills to support the department in the creation and approval of controlled documents in a timely manner
• Flexibility of working hours based on business needs, may include some nights and occasional weekends

Demonstrates expertise in GMP compliance and quality control processes, including analytical techniques such as HPLC, UPLC, and GC. Proficient in writing and revising SOPs and specifications while maintaining meticulous documentation and effective communication within a team environment.