Quality Control Project

Faith Cainion

• email: actdby@r.postjobfree.com • Phone: 320-***-**** • LinkedIn: http://www.linkedin.com/in/faithcainion •

Profile

Skilled Scientist and Leader with comprehensive experience in Quality Control, Project Management, Biochemistry, Manufacturing Operations, Molecular Biology, Stability, Method Development, Process Improvement and R&D. Hands on management experience supervising two manufacturing teams. Experienced in operating in an ISO 9001 certified environment adhering to 5S, GMP, GLP and ISO 13485 requirements.

Skills

Core Skills – Supervisory, Project management, Stability, Method development, CAPA, Technical presentations

Lab Skills – Next generation Sequencing, wet chemistry, titration, PCR, stability testing, microbiology, dilutions

Equipment – Proficient using Genome sequencers GS FLX,FLX+ systems and GS Junior, UV-Vis Spectrophotometer, Pipettes, Agilent 2100 Bioanalyzer, Accuri Flow Cytometer C6, Luminoskan, Beckman Coulter Counter, Thermocycler, HPLC

Certifications/Training – Biotechnology Project Management, Lean 6 Sigma Yellow belt, HPLC

Computer Skills – Minitab, SAP, MS Project, MS Access, LIMS systems, MS Office

Professional Experience

Roche, 454 Life Sciences - Branford, CT 2008 – 2015

Quality Control Laboratory Supervisor (2014 – 2015)

Led a team of 3 direct reports and 4 supporting team members to successfully meet operational key performance indicators. Developed and motivated team to achieve peak performance during impactful organizational changes.

Maintained laboratory workflow and established priorities and time lines for Quality Control and Critical Component Manufacturing groups, ensuring compliance to quality standards, productivity goals and deliverables, achieving > 95% OTIF.

Strategically scheduled testing activities, managed execution of methods and procedures for inspecting, testing and evaluating product quality.

Initiated and led investigations for Non- Conforming and Out of specification material through OOS, NCR and CAPA reporting processes. Organized and run troubleshooting meetings, established experimental plans and provided resolution into root cause analysis.

Established, managed and maintained precise QC standards and participated in audits to ensure compliance to GMPs, GLPs and ISO9001

Senior Quality Control Analyst (2013 – 2014)

Selected as the Operations Project Manager for a reagent product and software launch. Ensured the project was running on track per the scheduled project timelines, tracking the project deliverables, managing resource allocation and constantly monitoring and reporting the project progress.

Facilitated weekly Operations project team and ad hoc troubleshooting meetings to discuss status and updates ensuring the product was launched on time, quality and budget. Recipient of Roche Applaud award for the accomplishment.

Validated and transferred new products and functional methods from R&D to QC ensuring new methods and specifications were accurate. Authored new test methods, reagent specifications and test sheets for the new products.

Tracked and trended data on QC quality metrics and presented in cross functional meetings.

Organized, scheduled and facilitated trainings and presentations of various R&D topics to the QC group.

Served as Quality Control team lead and carried responsibilities of supervisor such as scheduling and data reporting during supervisor’s absence.

Valuable contributor in troubleshooting efforts, method transfers and product launch activities by performing validation runs, lot trace investigations, data compilation and analysis of results.

Quality Control Analyst II (2011 – 2013) / Quality Control Analyst I (2008 – 2011)

Led, managed and executed a project to validate a change in shipment and storage conditions directly resulting in the reduction of customer complaints and shelf life extension. Recipient of Operational Excellence Award for outstanding achievement for the validation project.

Conducted routine and non-routine analysis of raw materials, bulk compounds, and finished products according to standard operating procedures ensuring product quality. Performed enzymatic assays, DNA sequencing, emPCR, library preparation and standard molecular biology techniques.

Appointed QC representative responsible for supporting stability group with test requests generation, sample submission, data reconciliation and reports.

Supported the development, revision and validation of test methods including data compilation, review of specifications, report and update of standard operation procedures.

Key contributor in CAPA groups to improving complex work processes and address product issues.

Managed instrument calibration and sample retain programs for QC and Method Development teams.

Unilever - Trumbull, CT 2008

Laboratory Technician

Prepared antiperspirant and deodorant samples for analytical, stability testing.

Organized and coordinated sample testing using the Unilever RADMIS and LIMS systems to track and trend stability data.

Saint Cloud State University - Saint Cloud, MN 2005 - 2007

Undergraduate Research Associate

Performed undergraduate research on the development of an alternative drug treatment for diabetes. Individually established a method and used it to study the radical scavenging activities of potential antidiabetic synthesized and characterized vanadium flavonoid complexes.

Recipient of Denise M. McGuire Research Award Grant. Presented the research in the Saint Cloud State research colloquium and Saint Cloud state chemistry department senior thesis presentations.

Education and Certifications

University of Washington 2015

Biotechnology Project Management Certificate

Saint Cloud State University - Saint Cloud, MN 2007

BS Biochemistry (ACS Approved)

Advance Training

Lean Six Sigma Yellow Belt training

Design for Quality and Manufacturability (DQM) - Design of Experiments training

Design for Quality and Manufacturability (DQM) - Process Capability and Control Training

Practical HPLC & UHPLC Basics, Equipment and Troubleshooting Training

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