Experience

Ascension Public Schools

• United States
• Education Administration Programs
• 1 - 100 Employee

• Kindergarten Teacher

  • Aug 2019 - Present



Kelly Services

• Substitute Teacher

  • Jan 2019 - May 2019

  Performs duties as a substitute teacher in various grade levels from Pre-K through 5th grades in the Ascension Parish School District. Schools worked at include: Lakeside Primary, Lake Elementary, Galvez Primary, Central Primary, and Oak Grove Primary. Follows teacher prepared lesson plans when available. Creates lessons and activities “on-the-fly” based on work being performed in the classroom when lesson plans were not available. Handles discipline according to classroom and school expectations.



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Stability Coordinator

  • 2013 - 2018

  Mallinckrodt Manufacturing (INOmax) - Maintained stability program for cGMP facility. Wrote and executed stability protocols for new and existing products. Reviewed, maintained, and tracked stability testing data to confirm/establish expiry of product. Drafted stability closure reports and stability section of annual report. Performed final departmental review of quality control testing for API, intermediate, and finished drug products.• Participated in the implementation of a new Labvantage LIMS system, going paperless across systems. • Revised stability protocols to a more user friendly document in a standard format, significantly reducing paper waste. • Cross trained in performing analysis for finished products.



IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Services Coordinator

  • 2011 - 2013

  Conducted review and disposition of manufacturing and laboratory batch records. Wrote, reviewed, and approved procedures in electronic documentation system (Documentum and Master Control). Coordinated, tracked, and performed investigations into product quality complaints (Navision and Master Control). Assisted with regulatory agency audits. Co-created training curricula for all facility positions. Trained personnel on quality procedures. Tracked deviations, non-conformances, and CAPAs (Master Control).• Compiled documents and presented monthly and annual quality metrics to site management.• Organized and wrote annual product reviews. • Oversaw war room process for regulatory, customer, and internal audits.

• Quality Assurance Auditor

  • 2008 - 2011

  Performed internal and supplier audits. Wrote and maintained, internal, and supplier audit reports and schedules. Trained personnel on quality procedures relating to audits. Provided backup to issuance of deviations, non-conformances and holds. • Assisted in completing regulatory agency audits resulting in zero 483’s being issued. • Maintained a high level of product quality consistently ensuring annual zero product recalls.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Formulations Supervisor

  • 2005 - 2007

  Wrote and approved formulation records and procedures prior to activation. Reviewed and corrected records within formulations department. Drafted, reviewed, and approved deviations, investigations, and CAPAs, using TrackWise system. Wrote, reviewed, and approved change controls. Scheduled staff for upcoming shifts. Trained employees on company procedures and regulatory requirements. Supervised personnel in formulations and equipment cleaning.

• Formulations Specialist

  • 2004 - 2005

  Reviewed and performed calculations in batch records prior to formulations. Wrote and performed investigations and deviations for formulations department. Reviewed and approved formulations records prior to activation. Analyzed and corrected records within formulations department. Trained employees on regulatory requirements and assisted management with training programs on company procedures.

• Documentation Analyst

  • 2003 - 2004

  Performed technical analysis of sterilization records. Answered customer questions on batch records. Wrote and dispositioned investigations on sterilizations and customer products.

• Quality Assurance Auditor

  • 2002 - 2003

  Organized and performed internal audits of production areas (concentrating on setup of filling lines). Ensured adherence to SOPs. Wrote and dispositioned investigations and deviations to cGMP processes. Maintained some interactions with customers to address issues during formulation and filling phases.

• Documentation Auditor

  • 2000 - 2002

  Performed technical analyses of manufacturing procedures and process documentation. Reviewed and compiled manufacturing documents, checking for completeness, accuracy, and acceptability according to cGMPs. Ensured continuous adherence to essential SOPs.