Sr. Scientist, Quality Control

Responsibilities

• Independently perform routine and non-routine analytical testing of in-process, release, and R&D samples in compliance with approved methods, specifications, and cGMP requirements
• Maintain advanced technical proficiency in analytical instrumentation, with required expertise in HPLC systems and chromatographic data systems (e.g., Empower); proficiency with additional QC instrumentation (e.g., GC, dissolution, Karl Fischer, particle size, spectroscopy) is a plus
• Troubleshoot, maintain, and help optimize laboratory instrumentation, working with vendors as needed to resolve complex equipment issues and minimize downtime
• Lead the technical aspects of laboratory investigations, including deviations, OOS, and atypical results
• Contribute to method lifecycle activities including method development, qualification, validation, transfer, and revalidation
• Apply scientific principles, critical thinking, and sound judgment to solve complex technical problems
• Author and review quality system documentation, including SOPs, protocols, deviations, OOS investigations, CAPAs, and change controls
• Perform technical review of GxP and other laboratory documentation in accordance with Good Documentation Practices (GDP) and ALCOA+ data integrity principles
• Help maintain a safe, organized, and inspection-ready laboratory environment, including proper management of samples, standards, reagents, and supplies
• Serve as a QC technical SME during regulatory inspections
• Serve as a technical mentor and resource for QC team members, including informal coaching, training on techniques and instrumentation, and peer review of analyst work

Requirements

• Minimum of a B.S. degree in Chemistry, Biochemistry, or a related discipline
• Minimum of 10 years hands on experience in a commercial cGMP pharmaceutical QC laboratory
• Strong, hands-on understanding of cGMP regulations, data integrity expectations, and documentation practices
• Proven experience authoring and reviewing quality system documentation (e.g., deviations, OOS investigations, SOPs, change controls)
• Advanced knowledge of HPLC operation, maintenance, and troubleshooting
• Strong analytical, problem-solving, and critical thinking skills with exceptional attention to detail
• Able to manage multiple priorities in a fast-paced, regulated environment
• Excellent written and verbal communication skills

Benefits

• Competitive compensation package
• Comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP