QC Supervisor

Awo Rage ac2qry@r.postjobfree.com

***** *

Bloomington

Freeway

Bloomington,

MN

55431 678- 687- 8820 Objective: To obtain a management position that will allow me to utilize my extensive experience in Food science/pharmaceutical/ Clinical field.

Accomplishments:

• Set up Genova diagnostic’s new Microbiology lab which involved training of technicians on plate reading, installation of VITEK MS and VITEK 2, implementation of CAP quality control requirement, relevant NCCLS guidelines and use of automated plate streaker- Vista ISOPLATER.

• Trained employees on following rapid test instruments such as DuPont Real time PCR and Biomerieux’s VIDAS for Salmonella, Listeria and Campylobacter. Also, utilized Applied Biosystem’s 3130 DNA sequencer, Biomerieux’s VITEK2 and DuPont Ripoprinter for Unknown analysis.

• Performed implementation of following Food microbiology analysis such: Aerobic plate count, Staph- coagulase positive, Most probable number for Coliform and E.coli, and Yeast/ mold on finished products such cheese, cakes, fresh produce, spices, ready to eat sandwiches, and school lunches. Also, performed analysis on environmental samples from production plants and raw meat such as poultry and meat.

• Remodeled wuxiapptec General Micro lab to increase efficiency and reduce lab turnaround time and nonconformance’s.

• Specializes employee development & retention, process definition, problem definition and root cause analysis

• Monitoring key metrics (and developing if none exist) for measuring efficiency, productivity, inventory, quality and taking necessary corrective actions when goals are not met

• Excellent knowledge of Microsoft Office including Outlook, Excel (advanced), Word and PowerPoint Dendreon (Valeant Pharmaceuticals, Inc.)

Manufacturing Operations Coordinator October 2016 –August 2017

• Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.

• Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.

• Executes corrective actions and develops innovative ideas for process improvement.

• Train new team members, mentor Manufacturing Associates and sets example as team leader.

• Collaborates with department in cross-functional teams, projects and GXP-related problem resolution and troubleshooting.

• Responsible for a variety of GMP and non-GMP activities in regards to material receipt, inventory ordering and management, product processing, final product packaging/labeling, and other functions required to support operations.

• Interfaces with internal stakeholders and third-party vendors to plan GMP material activities to support Manufacturing.

• Provides direction to other Manufacturing Operations Associates.

• Monitors, audits & resolves material issues in Enterprise Resource Planning system (ERP) and LIMS.

• Monitors and prepares records of merchandise shipped.

• Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.

• Examines stocks and distributes GMP and non-GMP materials to inventory and manufacturing lines. Genova Diagnostics.

Technical Supervisor, Microbiology September 2013 – February 2016

• Primarily handled bio-hazardous stool specimens while following universal handling precautions for all specimens.

• Ability to utilize all equipment and procedures in assigned area. Provides support and coverage at the bench level as needed

• Trained staff on reading prepared culture media e.g. HE, XLD, SS, MAC, EMB, TSA and SAB.

• Scheduled and assigned all staff workloads to ensure that all tests meet required TAT.

• Reviewed all QC prior to any results being released.

• Assured all reagents were made & labeled correctly, and expired or defective reagents are replaced.

• Implemented department quality control, monitored techs are recording it and performed monthly review of data and corrective action for each test is documented.

• Trained employees on all new equipment and ensured equipment preventive maintenance is performed and documented.

• Ensured proficiency materials are handled exactly as patient samples according to each tests documented protocol.

• Implemented SOPs and ensured proper documentation, updating as needed and performing yearly review.

• Ensured all new employees are trained and their competency is documented before putting them into production on a method. Ensured continued employee competency is measured during their first 6 months and 1 year anniversary, then yearly thereafter.

• Implemented employee development plan within area of responsibility. Met with employees quarterly to review and define expectations or more frequent if needed.

• Participated company audits such as FDA, USDA, CMS, client audits and corporate.

• Ensured all supplies and reagents are ordered as needed and no systems are down due to delayed ordering.

• Held regular department team meetings and attended management meetings to ensure dissemination of information from upper management.

WuxiAppTec Inc.

Microbiology Lab Supervisor November 2010 – April 2012

• Reviews/approves quality control records for completeness, accuracy, and acceptability of results.

• Scheduled departmental day-to-day activities according to company’s production requirements and oversees employee staffing levels.

• Performed second review of all microbial IDs generated, by ensuring Gram stain and biochemical analysis were consistent prior to generation of Certificate of Analysis.

• Communicated with clients on issues related to ID’s such as delays and source of organism recovered.

• Maintained instrument maintenance of in-house and vendor requirement.

• Performed growth promotion for all media used in the facility.

• Coordinated employee training and competency activities and ensured that the appropriate training and competency records are completed.

• Performed employee appraisals. Identified and documented, under the direction of Human Resources department, any employee disciplinary actions.

• Initiated, developed and reviewed SOPs, forms, and flow charts and ensures that all department employees follow all SOPs, FDA, ISO 17025, EU, 21 CFR and OSHA requirements.

• Completed investigations, root cause analyses, and reports for out-of-specification results and deviations.

• Maintained department’s inventories and department’s statistics by utilizing lean sigma measurable metrics such as TAT and right-the-first-time and ensures adequate resources

• Interacted cooperatively and communicates effectively with coworkers, supervisors, or managers of other departments and receives direction well from superiors.

• Attended weekly senior leadership meetings and disseminates information and expectations to team members

Sterility Supervisor/Sample Receipts October 2008 – August 2010

• Handled personnel issues, including scheduling of time off, timesheets and conducting employee performance reviews.

• Initiated client technical procedures for sterility samples by determining their Bacteria stasis and Fungi stasis properties by utilizing aerobic and anaerobic media.

• Monitored department metrics such as RFT, overtime and on-time delivery etc.

• Scheduled and reviewed EM for ISO 5, 7 and 8 areas and department water sampling.

• Reviewed client technical procedures, assisted staff with testing complex products in the cleanroom.

• Closely monitored training and signing off of new hire such as gown qualification.

• Communicated with clients on sterility failures, testing requirements, potential problems and provided possible solutions.

• Oversaw inventory to ensure that all supplies are stocked for routine testing/laboratory needs.

• Identified training needs and worked with department to ensure implementation of training to address those needs.

Silliker Inc. (Merieux Nutrisciences)

Operations Supervisor (Diagnostics and Sample Prep) August 2004 - Sept 2008

• Supervision of daily activities of department personnel.

• Assisted with developing, implementing, and maintaining quality programs (HACCP; Microbiological programs, vendor certification; raw materials; recall; hold and release of data; GLP, and ISO 17025).

• Ensuring daily procedures are in compliance with FDA and USDA.

• Participation in Human Resource programs to better develop the understanding of recruitment and retention processes.

• Assisting department personnel with analysis and evaluation of tasks to ensure time sensitive deadlines are met.

Client Service Representative (Promotion) July 2003 - August 2004

• Answered questions from client and laboratory personnel concerning on in-coming samples.

• Provided level of service that either met or exceeded customer requirements and rapidly responded to customer inquiries such as: identifying customer requirements, providing results and determining pricing, etc.

• Acted as liaison between lab personnel and client service department in regards to client complaints.

• Maintained knowledge if Laboratory Management System (LIMS) that was required to complete job responsibilities.

Quality Assurance Analyst (Promotion) August 2002-July 2003

• Provided excellent customer service to new and existing clients.

• Research and resolution to customer inquiries and concerns.

• Ensured company standards are met by following time sensitive guidelines in accordance with microbiological research procedures.

• Evaluating and approving product specifications for Silliker, Inc in various categories.

• Promoted programs for Silliker, Inc microbiological research.

• Going above and beyond to ensure customer requests are handled appropriately. Microbiologist August 2001-August 2002

• Analyzed and recorded data to produce an accurate and quality report for important company clients.

• Prepared samples for testing such as Aerobic plate count, Yeast and Mold, Staph-CPS, Coli form and E.coli.

• Performed Rapid tests such as ABAX -PCR and VIDAS e.g. Salmonella, Listeria and Campylobacter. Confirmation tests such E.coli O157:H7, Salmonella, Listeria and Campylobacter.

• Development and reporting of laboratory research to provide identity and destruction of Microorganisms in client provided products.

• Gaining the understanding of relevant microbiological testing procedures.

• Conducting problem solving activities for Silliker, Inc operation departments and suppliers.

• Maintaining accurate quality control documentation for procedures analysis.

• Performed tests on presumptive plates or tubes to identify strain of specific bacteria. Specialized Training:

• Managing Performance and Situational Leadership.

• Senior Situational Leader and Mentor program.

• Employment Law training.

• Campylobacter spp. Isolation and Identification from foods workshop at Auburn University

• AAMI workshop: Association for the Advancement of Medical Instrumentation

• ASM 2014 General Meeting: American Society for Microbiology

• VITEK® MS instrument, train-the-trainer course at bioMerieux customer service center in Durham, NC Education:

University of Windsor Windsor, Ontario

Bachelor of Science in Biological Sciences Completed 2001 References available upon request

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