Brenda Griffiths Email & Phone Number

Baton Rouge, LA, US

Gonzales, Louisiana

Baton Rouge, Louisiana Area

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.

Port Allen, Louisiana

• 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.
• Participated in the implementation of a new… Show more Mallinckrodt Manufacturing (INOmax) - Maintained stability program for cGMP facility. Wrote and executed stability protocols for new and existing 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. Show less

Port Allen, Louisiana

• 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.
• 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. Show less

Port Allen, Louisiana

• 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.
• 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.

Bedford, Ohio

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.

Bedford, Ohio

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.

Bedford, Ohio

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

Bedford, Ohio

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.

Bedford, Ohio

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.

Bachelor'S Degree, Mathematics

Practioner'S License, Early Childhood Education And Teaching

Currently doing my field experience at GW Carver Primary 3rd grade ELA and Math

Professional, Technical, Business, And Scientific Writing

Took graduate level technical writing classes to enhance my technical and scientific writing abilities.