Dia Luck
Bloomington,IN
Summary
Professional leader with strong emphasis on team collaboration and results-driven management. Adept at overseeing operations, optimizing processes, and ensuring adherence to high standards. Reliable and adaptable, skilled in conflict resolution, strategic planning, and fostering productive work environment. Enthusiastic about driving performance and contributing to organizational success.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Senior Supervisor, Quality Assurance
Novo Nordisk
08.2022 - Current
- Oversaw daily operations, ensuring compliance with cGMP regulations and company policies.
- Analyzed operational processes, identifying areas for cost reduction and productivity enhancement.
- Recruited, hired and trained staff and provided ongoing feedback and performance evaluations for development.
- Maximized personal competency through continuous professional development.
- Mentored staff, enhancing team performance and knowledge retention.
- Strengthened cross-functional collaboration, leading to more cohesive teamwork and better overall results.
- Streamlined workflows to improve efficiency and reduce operational delays.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
Value Stream Supervisor - Secondary
Catalent Biologics
04.2021 - 08.2022
- Oversaw daily operations, ensuring adherence to quality standards and regulatory compliance.
- Implemented process improvements that reduced waste and increased overall productivity.
- Enhanced workplace safety, conducting regular audits and enforcing strict adherence to guidelines.
- Implemented standard work practices across the team for consistent results and improved communication.
- Managed process improvements to minimize waste, reduce costs, and optimize overall value stream flow.
- Fostered a culture of collaboration, encouraging open communication between team members for problem-solving and innovation.
- Increased employee engagement through regular feedback sessions, skill development programs, and recognition initiatives.
- Ensured compliance with regulatory requirements by maintaining up-to-date documentation on policies, procedures, and training records.
- Resolved conflicts between team members and addressed complaints or grievances.
- Evaluated team performance and provided feedback on areas requiring improvement.
- Scheduled shifts and shift changes to accommodate workload and customer needs.
Senior Process Engineering Technologist
Catalent Biologics
10.2020 - 04.2021
- Gather and analyze data as required
- Provided technical support for internal teams, assisting in the resolution of various engineering-related issues.
- Implemented cost-saving initiatives without compromising quality or performance standards.
- Collaborated with stakeholders to define project requirements, aligning engineering objectives with business goals.
- Spearheaded continuous improvement initiatives, achieving enhanced productivity through systematic process evaluations.
Quality Assurance Representative
Catalent Biologics
09.2019 - 10.2020
- Review Drug Product Batch Records and identify any corrections, events, or deviations and work toward getting them corrected prior to the record being dispositioned.
- Disposition completed Batch Records in order to hit End of Month goals to obtain revenue from the customer.
- Exhibited strong attention to detail when reviewing batch records, ensuring clean record reaches the clients.
- Accurately documented all pertinent information related to formulation, filling, inspection and packaging, including batch records, equipment logs, and deviation reports, ensuring data integrity and regulatory compliance.
Customer Order Specialist
Home Depot
02.2018 - 07.2019
- Daily management and organization of over a hundred ongoing customer projects; working as a liaison between the customer and the installers.
- Problem solve as issues arise, ensuring customer satisfaction always.
- Creating and maintaining Purchase Orders as needed.
Incoming Inspection Supervisor
Boston Scientific
08.2014 - 10.2017
- Oversight of day-to-day business for the Incoming Quality Assurance area with 10 inspectors.
- As the Subject Matter Expert for Incoming Quality, I ensured the area was in a constant state of audit readiness: supporting both internal and external auditing bodies (inclusive of FDA, BSI, DEKRA, etc.). I was the Subject Matter Expert during the audits speaking directly to auditors regarding my expertise.
- Generated monthly metrics and presented on both a weekly and monthly basis to staff.
- Worked closely with New Product Development projects to ensure the materials needed for new product builds were available in order to hit critical launch dates.
- Implemented process improvements that reduced inspection cycle time while maintaining product quality standards.
- Collaborated with cross-functional teams to resolve defects and drive corrective actions effectively.
- Developed inspection plans and schedules to optimize workflow and resource allocation across projects.
- Conducted root cause analysis for non-conformities, leading investigations to prevent future occurrences.
- Led audit preparations, fostering a culture of continuous improvement in compliance and operational excellence.
- Reduced inspection errors by implementing a robust quality control system.
- Ensured compliance with industry standards and regulations through thorough inspections and rigorous documentation practices.
- Increased productivity by effectively allocating resources and optimizing schedules for inspections.
- Resolved conflicts amongst team members efficiently while maintaining clear lines of authority within the department.
- Cultivated professional working relationships with peers and supervisors.
Senior Quality Assurance Technician
Boston Scientific
03.1994 - 08.2014
- As the site Quality Notification Administrator, I Implemented and managed SAP containment controls due to quality concerns, pre-production builds, and business needs such as new product launches.
- As the site Product Inquiry Report (PIR) Coordinator, I coordinated and facilitated meetings with required team members (Quality, Regulatory, and Medical) to determine whether a quality issue needed to be elevated.
- Collaborated with cross-functional teams to troubleshoot and resolve quality issues efficiently.
- Led root cause analysis initiatives to address non-conformances effectively.
- Contributed to continuous improvement initiatives by actively participating in regular team meetings and sharing insights about potential areas of improvement.
- Provided training on quality assurance best practices for new employees, fostering a culture of excellence within the organization.
- Improved product quality by conducting thorough inspections and identifying defects in the manufacturing process.
- Assisted in external audits, showcasing company''s commitment to maintaining high-quality standards throughout its operations.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
- Ensured timely resolution of non-conformance issues by effectively communicating findings to relevant departments and recommending corrective actions.
Education
High School Diploma -
Bloomington High School North
Bloomington, IN01.1987
Skills
- Microsoft Office: Word, Excel, PowerPoint, SharePoint
- FDA CFR 21 Regulations: Well versed in the regulations required for medical device manufacturing
- ISO 9001: I am knowledgeable regarding the standards for medical device manufacturing
- Project management
- Data analysis
- Employee supervision
- Staff development
- Compliance
- Decision-making
- Documentation and reporting
- Complex Problem-solving
- Process monitoring and improvement
Certification
- Certified Mechanical Inspector, ASQ
Timeline
Senior Supervisor, Quality Assurance
Novo Nordisk
08.2022 - Current
Value Stream Supervisor - Secondary
Catalent Biologics
04.2021 - 08.2022
Senior Process Engineering Technologist
Catalent Biologics
10.2020 - 04.2021
Quality Assurance Representative
Catalent Biologics
09.2019 - 10.2020
Customer Order Specialist
Home Depot
02.2018 - 07.2019
Incoming Inspection Supervisor
Boston Scientific
08.2014 - 10.2017
Senior Quality Assurance Technician
Boston Scientific
03.1994 - 08.2014
High School Diploma -
Bloomington High School North
LEADERSHIP
I have worked in a leadership role throughout my career. I have been a mentor and liaison for many. I have strong interpersonal skills that make people feel comfortable with me, look up to me, as well as respect decisions I have had to make.