Commercial Quality Control Chemist II

Supervisory Responsibilities

• May supervise QC laboratory staff continually or on a project basis.
• May assist with recruiting, interviewing, hiring, onboarding, and training new staff.
• May oversee the daily workflow, testing priorities, and execution of assigned commercial QC activities.
• May provide technical guidance, coaching, and support to QC Chemists I and other laboratory personnel.
• May assist QC management with workload planning, resource allocation, and meeting commercial testing timelines.

Duties & Responsibilities

• Perform routine and non-routine analytical testing of commercial pharmaceutical products, including facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
• Demonstrate intermediate expertise with applicable analytical equipment and techniques, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, and other laboratory technologies as qualified.
• Execute approved analytical methods, compendial procedures, and laboratory SOPs in accordance with cGMP requirements, specifications, and established testing timelines.
• Ensure analytical data, calculations, laboratory records, and supporting documentation comply with Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory expectations.
• Technical Data Review: Perform technical review of analytical data, calculations, and supporting documentation for commercial testing, as assigned and within established qualification and authorization.
• Serve as a technical resource for laboratory investigations, including OOS, OOT, deviations, incidents, and unexpected analytical results, in collaboration with QC management and Quality Assurance.
• Assist with root cause analysis, corrective and preventive actions, and implementation of improvements resulting from laboratory investigations.
• Support the transfer, implementation, verification, and optimization of analytical methods for commercial products, as assigned.
• Assist QC management with daily laboratory workflow, testing priorities, resource coordination, and timely completion of commercial testing deliverables.
• Interface with clients and internal stakeholders on technical analytical matters, testing status, data inquiries, and laboratory concerns, as requested by QC management.
• Assist with the development, revision, and technical review of SOPs, specifications, protocols, reports, and other controlled documents.
• Support the training, mentoring, and qualification of QC laboratory personnel on analytical methods, instrumentation, procedures, and GMP practices.
• Maintain compliance with cGMP, GDocP, data integrity, laboratory safety, and applicable regulatory requirements while promoting a culture of quality and accountability.
• Identify and support opportunities to improve laboratory efficiency, testing accuracy, turnaround times, equipment utilization, and right-first-time execution.
• Assist with internal and external audits, regulatory inspections, and preparation of supporting laboratory documentation and records.

Required Skills & Abilities

Demonstrates intermediate expertise with analytical equipment and techniques applicable to commercial pharmaceutical testing, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, or other relevant technologies. Strong understanding of cGMP laboratory practices, Good Documentation Practices (GDocP), data integrity, and applicable regulatory expectations. Demonstrated ability to execute analytical methods and interpret analytical data accurately and effectively. Strong analytical, mathematical, troubleshooting, and problem-solving skills. Demonstrated ability to support OOS, OOT, deviation, and other laboratory investigations. Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Demonstrated ability to communicate effectively with coworkers, clients, and other internal and external stakeholders. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong collaboration and cross-functional teamwork skills. Strong technical leadership and mentoring skills. Ability to prioritize tasks and coordinate laboratory activities as appropriate. Ability to function well in a fast-paced and, at times, stressful environment. Proficient with Microsoft Office Suite or related software. Familiarity with LIMS, electronic laboratory systems, Empower, or other applicable analytical data systems preferred. Accepts feedback from a variety of sources and constructively manages conflict. Demonstrated commitment to quality, compliance, safety, and continuous improvement.

Education & Experience

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline, with 2 years of hands-on laboratory experience preferred; or
• Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline, with 1 year of hands-on laboratory experience preferred.
• Requires 1 year of GMP laboratory experience.
• Experience in pharmaceutical commercial QC testing preferred.
• Experience with applicable analytical instrumentation, laboratory investigations, and analytical method execution preferred.

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer.
• Prolonged periods of standing or sitting while monitoring laboratory equipment.
• Must be able to lift up to 15 pounds at times.
• Adheres to consistent and predictable in-person attendance.