Charlene King Email and Phone Number

• Oversee all QA functions and management at our finished good distribution center. This includes time/attendance, reviews, hiring/firing employees, and any disciplinary actions.• Manage all incoming inspection, review/release of CMO or sister site product through SAP/SOP processes (this includes Rx product, ORx product, DEA regulated products). Work hand in hand with CMO's and procurement to ensure C of C / C of A comply and are acceptable. Manage returned product, which includes recall product.• Manages UKG pro learning management for all South Carolina employees, SharePoint Admin, manage all CAPA/Deviations through Trackwise.• Lead personnel for any internal audits, this may include CMO's/DEA/DHEC and Board of Pharmacy. In addition, to audits, I was the lead on SAP integration for the QA warehouse functions and creation of all new Inspection Plans.• Designated representative for previous warehouse for the distribution of products.

• Oversee all QA functions and management at our finished good distribution center. This includes time/attendance, reviews, hiring/firing employees, and any disciplinary actions.• Manage all incoming inspection, review/release of CMO or sister site product through SAP/SOP processes (this includes Rx product, ORx product, DEA regulated products). Work hand in hand with CMO's and procurement to ensure C of C / C of A comply and are acceptable. Manage returned product, which includes recall product.• Manages UKG pro learning management for all South Carolina employees, SharePoint Admin, manage all CAPA/Deviations through Trackwise.• Lead personnel for any internal audits, this may include CMO's/DEA/DHEC and Board of Pharmacy. In addition, to audits, I was the lead on SAP integration for the QA warehouse functions and creation of all new Inspection Plans.• Designated representative for previous warehouse for the distribution of products.

• Handled disposal processes (include nonhazardous and hazardous product).• Incoming Inspection, review/release of products. In addition, processes all return product back into SAP.• Training of new employees and current employees.• Lead on Target audits that were performed monthly.• Work hand and hand with CMO's and Customer Service.

• Handles DEA/Rx Licensing • All aspects of drug listing to the FDA (monograph & ANDA products), which included creation of SPLs in ALiCE software.• Lead trainer of all new and current employees• Tech writer for creation/updating of SOPs/SWIs and forms• SharePoint Administrator for entire department, handled all GrapAll data when new product is developed and NDC's are assigned• Data entry into master data with mixability of formulation acceptability• Tracking and trending of all promotional material with project managers

• Inspection of manufacturing lines (liquid fill area, liquid mix, and labeling areas) to ensure all was GMP compliant• Handle all reworks, AQLs and split batches through SAP for components, liquids and finished goods• Back up CPO review/release of finished good products

• Inspection of incoming components, use of spec sheet for measurements acceptability (bottles, film, caps, desiccant, and dosage devices)• Proofit system inspection of all cartons, labels, inserts and promotional material• Handled all issues with C of C, C of A’s or problems with specifications for components with the CMO's

• Cleaning/processing through decontamination area (PPE/OSHA area)• Inspect, assemble the set instrumentation through SOP• Wrap sets and process through sterilization • Serviced OR & Outpatient surgical suites if addition instrumentation was needed for specific surgeries (some medical terminology used)

• Train all new and current employees on decontamination area (PPE/OSHA area), instrumentation inspections, sterilization and how to pick/stage orders for surgeries• Cleaning/processing through decontamination area• Inspect, assemble the set instrumentation through SOP• Wrap sets and process through sterilization • Serviced OR & Outpatient surgical suites if addition instrumentation was needed for specific surgeries (some medical terminology used)

• Update/Creation of SOPs• Answering multi--line telephones• Verification of weights of API product to be tested• Filing of analytical documents• Computer entry (Excel, Word, and Access)

• Review of resumes for current position open and weeding out of unqualified individuals• Processing and filing of confidential documents• Handled customer complaints by phone• Computer Entry (word and excel)

• Cashier• Customer Service• stocking general merchandise• Trained new and current employees on all aspects of the store and on customer service etiquette