Sr. QC Analyst

Job Description

Essential Duties and Responsibilities

• Monitor and support QC compliance with electronic systems and computerized laboratory applications.
• Support periodic review of electronic records and audit trails.
• Support inspection and audit readiness activities within QC.
• Participate in internal, customer, and regulatory audits/inspections.
• Assist in the preparation, review, and timely submission of responses to audit observations and requests for information.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform analytical testing of in-process material, bulk drug substance, finished drug product, stability samples, and raw materials
• Sampling, inspection and testing of packaging components upon receipt
• Proper documentation of all work according to cGMP and GDP
• Understand and applies the 21 CFR Part 11 requirements
• Maintains data integrity and compliance with regulatory standards
• Responsible for sampling of bulk API and bulk drums (API and raw material) for analysis by QC
• Prepare Quality Metrics for in-process, API, and FG turnaround times
• Perform calibration and minor troubleshooting on select laboratory instruments with appropriate training including GC, HPLC, UV/Vis, IR, Potentiometer, Refractometer, Karl Fischer, Density meter, Oven
• Perform validation of new lab instruments and equipment as required
• Perform daily general duties in a proper functioning QC lab like balance checks, glassware washing, gas cylinder changes, temperature record checks, inventory supplies including reference standards
• Assist other chemists in completing quality laboratory investigations in response to out of specification, out of trend, questionable results or in response to a lab deviation
• Manage and conduct investigations, as assigned and required, for laboratory events, change controls, CAPA, and deviations
• Oversee the training structure and conduct training for new hires as required
• Peer review of raw data of initial analysis to release material in a timely fashion
• Assist Lab Coordinator with stability put-ups or take-outs when necessary due to large volume of samples
• Assist QC Supervisor in the approval of stability packets in the required electronic system
• Able to create or review QC related documents as required

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Ability to serve as a QC Data Integrity and Compliance (DICO) Champion and promote a strong culture of data integrity, electronic compliance, and inspection readiness.
• Ability to interpret analytical data, identify trends, prepare quality metrics, and communicate findings effectively.
• Knowledge and practical understanding of electronic laboratory systems and computerized systems, including audit trails, electronic records, electronic signatures, user access, and system-generated data.
• Strong audit and inspection readiness mindset, with the ability to organize and provide accurate laboratory documentation and supporting information in response to internal, customer, and regulatory audits/inspections.
• Excellent verbal and written communication skills
• Creative and able to present various solutions
• Energetic, enthusiastic, and motivational disposition
• Maintain confidentiality
• Coaching skills

Education / Experience

• Bachelor’s degree or Associate’s degree in science
• 3+ plus years of experience in a QC lab environment
• Understand chemical processes and reactions
• Prior experience with data integrity, electronic compliance, computerized laboratory systems, or serving as a quality/data integrity champion is preferred
• Experience supporting internal, customer, or regulatory audits/inspections preferred.
• Awareness of cGMP, quality and safety norms and requirements in a regulated industry
• Usage of technology tools such as SAP, MS office, Ensur, Openlab, LabX, TrackWise, CaliberLIMS is preferred.
• Experience with quality metrics, laboratory performance monitoring, and trend analysis preferred.