Jennifer Beach-Hickerson Email & Phone Number

Madison, Wi, Us

Houston, Texas, Us

Assisting in internal audits and scheduling follow-ups when necessary. Writing Non-Conformance Reports, determining quality clauses based on AS9100 and ISO 9001 requirements. Reviewing material specifications and measurements based on drawings using calipers and micrometers. Preforming preventative maintenance tasks and reviewing standards on machinery. Providing and supporting zero harm throughout company. Calibrate internal hardware and coordinate external calibrations.

Edmond, Oklahoma, Us

I managed a newly developed small team to complete incoming materials and on the floor inspections for sterile compound 503b manufacturing. I built processes and authored SOPs that adhered to 21 CFR 210 & 211& 820. I observed behavior of manufacturing to ensure adherence to cGMP and documented observations and appropriate corrective actions. I acted a team leader and developed training guides and documented training. I trained staff on incoming inspections using AQL and Calipers. Assisted with the QC team and reported findings and helped create CAPA's based on continuous improvement throughout. Used my previous experience in pharmaceuticals to help correct the findings in the FDA consent decree that was previously issued to the company (2022).

Arlington, Va, Us

-Developed and maintained OKC site receiving inspection process- ensured it was compliant and uniform in inspection processes and adhered to Boeing standards at other sites.-Identified gaps in QMS with SQ department and corrected them as they came up, using my diversified background and experience to drive a different opinion on ISO 9001 regulations. -maintained and audited processes in warehouse and 3pL team.- Authored and maintained business process guide for the incoming and outgoing material.- Successfully assisted 3 audits with zero findings for the RI area.-Applied and audited procurement team and suppliers for accurate quality clauses.-Team focal for record requirements and internal website.-Notified notice of escapements to programs.-Assisted in NCRs and CA’s.-Developed training and training material for RI.

Oklahoma City, Ok, Us

QA Supplier Management with a focus on method development and report writing at the III level. I advised the SQ, RI, and Logistics teams on proper handling of chemicals and disposables across a total of 3 warehouses. I updated countless material specifications for Raw Materials and ensured that USP and EP guidelines for chemical testing were followed for each client all in various stages of development. Authored and navigated correspondence for supplier corrective actions and closed out corrective actions when appropriate. Assisted with critical delivery on weekends and evenings to ensure that client material was tested and released. Used Raman spectroscopy and developed new methods for device to save clients in early phase identification testing at testing labs as required in the EP and USP guidelines.Preformed chemical sampling and also visual inspection on vials.

Oklahoma City, Ok, Us

Introduced my team to basic manufacturing knowledge that was crucial in turning our production around and identifying non-conforming materials and chemicals before it got to manufacturing. Using my manufacturing training and connections across the company I was able to train the incoming material associates on aseptic techniques and gowning. I was the lead on in the moment material failures and could comfortably enter clean rooms throughout the sites to see and document failures in materials in real time to issue corrective actions and determine like for like parts that could be used from inventory. Assisted with change notifications to clients and manufacturing and pulling defective products from shelves. I assisted the lead auditor in SQ in desktop audits and determining audit criteria and questions that would be most helpful for products that were custom and single use.

Oklahoma City, Ok, Us

Authored investigations and deviations- both client facing and internal. Updated Standard operating procedures based on corrective actions or after annual review to ensure all procedures were accurate and being followed, corrected grammar and ensured uniformed structure throughout. Assisted the Operational Excellence team on the implementation of multiple lean projects. Assisted in the implementation of the training team and assisted in hands on lab work for new hires as well as gowning and aseptic techniques.

Oklahoma City, Ok, Us

Experienced in Bioreactors sizes 14L, 200L, and 1000L stainless steel as well as single use fermenters of varying sizes. Homogenizers, centrifuges, buffers and medias. Filtering, FIT tests, storage. GMP facility producing commercial and early phase clients. Editing and assisting with the production of batch records.

Seattle, Wa, Us

St Louis, Missouri, Us

Nichols Hills, Oklahoma, Us

Bolingbrook, Il, Us

Bachelor Of Science - Bs, Forensic Science And Technology

Bachelor Of Arts - Ba, Psychology

Associate Of Arts - Aa, Psychology