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Job Summary
We are looking for a Quality Control (QC) scientist to lead and perform advanced analytical testing, support method validation and transfers, and ensure full compliance with GMP standards.
Job Responsibilities
Analytical Testing & Documentation
- Perform and oversee advanced analytical testing of raw materials, finished products, and stability samples using validated methods including HPLC, GC, FTIR, and related techniques.
- Lead method verification studies in accordance with cGMP, regulatory, and internal requirements.
- Prepare and review method qualification and stability protocols and reports in accordance with applicable compendial guidelines (e.g., USP, EP, and ICH).
- Maintain and ensure the accuracy of documentation, reports, and laboratory records in strict accordance with GMP and data integrity standards.
- Review raw materials, finished products, stability data, and technology transfer documents against approved protocols and procedures.
- Coordinate end-to-end materials management including subsampling, external lab shipments, results review, and specification completion for timely material release.
- Maintain lab operations: monitor reagent/consumable inventory, initiate purchase orders, log incoming materials, and manage disposal per site and regulatory requirements
Data Integrity
- Serve as a data integrity champion within the QC laboratory, ensuring all analytical data, laboratory records, and electronic systems are maintained in full compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).
- Identify and escalate potential data integrity risks or gaps observed in QC laboratory practices, systems, or documentation, and support the implementation of corrective measures.
Technical Documentation & SME Support
- Author, review, and approve SOPs, specifications, test methods, change controls, protocols, and reports as a technical SME.
- Provide technical guidance to QC team members on method performance, instrument troubleshooting, and documentation best practices.
GSOP Implementation
- Lead and coordinate the site-level review, gap assessment, and implementation of Global SOPs (GSOPs) applicable to QC laboratory operations, ensuring local procedures are aligned with global standards and regulatory requirements.
- Collaborate with QA and cross-functional stakeholders to assess the impact of new or revised GSOPs on existing QC processes, methods, and documentation, and develop an implementation plan with clear timelines and ownership.
- Track and report on GSOP implementation progress at site, ensuring all required training, procedure updates, and system changes are completed within the established effective dates.
Supply Chain Notification Assessment
- Perform supply chain notification assessments in response to changes initiated by raw material suppliers, reagent vendors, or contract laboratories, evaluating the potential impact on QC test methods, specifications, analytical results, and product quality.
Change Control
- Demonstrate an in-depth understanding of the change control process as it applies to QC laboratory activities, including changes to analytical methods, instruments, reagents, and laboratory procedures.
- Initiate, author, and lead change control for QC-related changes, ensuring complete technical justification and all required supporting documentation prior to submission.
- Actively manage and track assigned change controls to ensure timely completion of all tasks and closure within established site timelines, escalating risks to QC management as needed.
Deviation & Investigation
- Demonstrate a thorough understanding of the deviation and investigation process, including initiation, execution, and closure from a QC laboratory perspective.
- Lead OOS/OOT and deviation investigations, applying structured root cause analysis methodologies (e.g., fishbone, 5-Why) to identify the true root cause and document findings clearly per GMP requirements.
- Develop risk-based, practical CAPAs as outcomes of investigations to prevent recurrence, and ensure timely follow-up and documented verification of CAPA effectiveness.
Project Management & Delivery
- Lead and manage QC-related projects such as method validations, instrument qualifications, GSOP implementations, compendial updates, and stability program expansions, ensuring delivery on time and within scope.
- Develop and maintain project plans, timelines, and status updates, communicating progress and risks proactively to QC management and cross-functional stakeholders.
- Collaborate cross-functionally with Manufacturing, QA, Regulatory Affairs, and Development teams to ensure QC project deliverables align with site and business objectives.
KPI Monitoring & Continuous Improvement
- Monitor, analyze, and report on QC KPIs including right-first-time testing rates, OOS/OOT frequency, investigation and CAPA cycle times, instrument availability, and compendial update completion.
- Identify adverse KPI trends, perform gap analyses, and lead or support corrective actions to restore performance targets.
- Champion continuous improvement initiatives within the QC laboratory, leveraging quality data and KPI outcomes to drive sustainable process enhancements.
- Ensure the QC Laboratory is maintained in a ready state of compliance for internal and external audits.
Job Requirements / Education / Competencies
- Bachelor of Science in Chemistry or a related field from a recognized educational institution
- Minimum of 1 year experience in a regulated pharmaceutical or laboratory environment
Additional Skills
- Master’s degree is an asset.
- Knowledge of Radiopharmaceuticals is an asset.
- Advanced laboratory computer skills including LIMS, chromatography data systems (e.g., Empower, Veeva), and related software.
- Proficient in Microsoft Teams, Microsoft Outlook, and other Microsoft products.
- Excellent written and verbal English communication skills, including the ability to present technical findings to cross-functional teams and management.
- Strong leadership and interpersonal skills with the ability to mentor and develop junior staff.
- Proven ability to manage multiple projects and competing priorities within established timelines.
- In-depth working knowledge of change control, deviation, investigation, and CAPA processes from a QC laboratory perspective.
- Must be willing to work flexible hours, including early mornings, late evenings, or weekends, as required by project or operational needs.
LILLY CORE EXPECTATIONS (R2–4)
INCLUDE
Influences & collaborates across peers, teams, and functions.
Listens to learn & understand different views.
Builds relationships across dimensions of difference.
Speaks up with ideas, concerns & to ensure safety of others.
Asks questions & invites others to contribute.
INNOVATE
Anticipates & resolves key technical problems impacting function or project.
Thinks creatively, tries new ideas & applies learnings.
Anticipates, embraces & adapts to change.
Invests in personal development & growth.
Is curious & seeks input from others.
ACCELERATE
Makes decisions based on available information impacting function or project.
Is effective, efficient & decisive.
Is goal & solution-focused.
Is proactive, positive & determined.
Seeks help & support from others when needed.
DELIVER
Impacts own projects, peers, team and/or across teams/business areas.
Performs high quality work.
Demonstrates courage & integrity.
Shares insights & collaborates with others.
Follows through on commitments.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$69,000 - $128,700
Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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