Senior Quality Control Lab SME

About this role

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

What You Will Achieve

In this role, you will: • Serve as a scientific/technical representative for process-and product-related issues at the site; partner with Manufacturing, Quality, Engineering, Technical Services, Validations, Center One, above site teams and other functions to resolve issues and support business priorities.

• Lead or support investigations for complex events (e.g., laboratory investigations, deviations/exception reports, quality events, complaints, incoming materials, and finished product) including interviews, system reviews, data analysis, and documentation of conclusions.

• Identify root cause and develop, implement, and verify effectiveness of corrective and preventive actions (CAPA); monitor trends to prevent recurrence and drive toward zero defects.

• Support technology transfers and start-up of new products, processes, equipment, or manufacturing lines; help ensure readiness to meet production schedules, maintain compliance, and uphold product quality.

• Lead, develop and execute method validation, method verification, method transfer, method remediation and process validation activities.

• Design and execute studies/experiments (including scaled-down or laboratory models where appropriate) to generate critical data for troubleshooting, investigations, and process changes.

• Develop, review, and/or approve technical protocols, investigation summary reports, regulatory submission documents and other technical documentation; ensure clear scientific rationale and strong technical writing.

• Support installation, validation/qualification, and ongoing maintenance of analytical or laboratory equipment.

• Develop and maintain standard work, including Standard Operating Procedures (SOPs), templates, and training materials to standardize practices and improve consistency.

• Participate in continuous improvement initiatives and operational excellence projects (e.g., Lean/Six Sigma approaches) and apply structured problem-solving tools.

• Mentor and train colleagues; provide guidance on investigation practices, technical methods and instrument operations.

Here Is What You Need (Minimum Requirements)

•   Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Relevant experience in a regulated manufacturing environment (e.g., pharmaceutical science/engineering, technical services, quality, investigations/CAPA, validation/qualification, or laboratory analytical support).

• Strong problem-solving skills and demonstrated ability to organize data from multiple sources, extract key information, and document conclusions in quality systems.

• Excellent oral and written communication skills, including strong technical writing and the ability to communicate with cross-functional stakeholders.

• Ability to manage multiple priorities and deliver results with minimal supervision in a fast-paced environment.

• Proficiency with standard PC software (e.g., MS Word, Excel, PowerPoint; other tools such as Project as applicable).

Bonus Points If You Have (Preferred Requirements)

• Experience with FDA and global regulations/guidelines related to drug products, devices/container closure systems, and validation/qualification expectations.

• Experience authoring protocols and technical reports; method development/validation experience.

• Experience leading complex, cross-functional investigations and issue resolution; familiarity with Green Belt/Black Belt tools.

• Experience with statistical analysis software (e.g., JMP, Minitab) and using data to drive decisions.

• Certification(s) such as ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), and/or Six Sigma Green Belt.

• For laboratory/particle characterization assignments: hands-on experience with stereomicroscopy, polarized light microscopy, SEM, micro-FTIR, and particle/defect characterization; microscopy/SEM training (e.g., McCrone Group or university training).

• Knowledge of extractables/leachables study design or testing support.

• Experience with Laboratory Information Management Systems (LIMS).

• Ability to mentor and train junior colleagues

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

    PHYSICAL/MENTAL REQUIREMENTS • Ability to work effectively in a fast-paced environment, remain organized in ambiguous situations, and interface with multiple stakeholder groups.

• For laboratory-based assignments: ability to perform work in a laboratory setting, including extended periods of sitting and standing and sustained mental/visual concentration while operating instruments and preparing detailed documentation.

• Ability to analyze and interpret technical data and draw scientifically sound conclusions.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• May be required to provide non-standard hour support, including occasional weekends/holidays or on-call coverage, to support 24/7 manufacturing and investigation ti

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