ANGELA McKINLEY 828-***-****

Lenoir, NC ***** adr09r@r.postjobfree.com

www.linkedin.com/in/angela-mckinley

EXPERIENCED PROJECT MANAGER

A highly resourceful project manager, meeting customer needs across multiple industries. Expertise in manufacturing operations, facility shutdown management, and sourcing new equipment/supplies. Knowledge of user requirements, procuring contractors, and negotiating pricing for operations. Adept at coordinating projects and meeting aggressive timelines. Excellent communication skills and collaborates well with all levels of management. Goal oriented, resourceful, and welcomes a challenge.

Investigations Data Analysis Training

Validation Change Control Contracts

PROFESSIONAL EXPERIENCE

Seqirus (Info Quest Consulting), Holly Springs, NC March 2021 - July 2022 Project Manager

● Authored Change Controls to support manufacturing of a clinical trial drug including: new equipment, existing equipment updates, facility updates, and the Master Change Control for Phase 1 of the clinical trial

● Tracked the enrollment of materials to support a phase 1 clinical trial

● Liaison between Operations and TD for GMP readiness for clinical trial drug manufacturing

● Created and managed timelines for projects aligning with program timelines Exela Pharma Sciences, LLC, Lenoir, NC 2016 – June 2020 Operations Support Specialist

● Worked on Process Improvement Projects to support Operations at multiple manufacturing facilities

● Created project budgets and proposals including timelines, materials, and validation needs

● Procured of new equipment and supplies

● Obtained asset numbers

● Worked with vendors to design or rework equipment in order to streamline processes while maintaining GMP compliance

● Managed Michelle facility shutdowns from 2017 through 2020

● Authored shutdown protocols

● Initiated and managed change controls for process improvements which impacted product batch records

● Served on the change control review board

● Responsible for Operations CAPA (Corrective Action Preventive Action) which impacted the Michelle facility

● Performed investigations for manufacturing deviations and non-conformances for calibrated equipment

● Conducted training for new employee orientation

● Wrote, updated, and reviewed Standard Operating Procedures (SOPs) Associate Project Manager of Engineering

● Coordinated meetings and mapped the timelines for the implementation of a new manufacturing facility.

● Lead team in vendors and procurement selection of equipment for the new plant.

● Attended Factory Acceptance Test (FAT) for new equipment.

● Worked with upper management and vendors on pricing, contracts, safety agreements, and design specifications for new equipment.

● Worked with the finance department on budgeting and payment schedules. Validation / Engineering Coordinator

● Executed validation protocols, performed data entry, and reviewed executed protocols.

● Approved invoices and created purchase orders for the Engineering department. Fresenius Medical Care, Conover NC — CCHT 2008 - 2011

● Performed hemodialysis treatments on patients

● Performed quality checks on the water system

● Compounded dialysate solution to be used in treatments

● Administered approved medications as needed for treatment

● Performed weekly maintenance tasks for equipment ANGELA McKINLEY 828-***-**** Page Two

Skill Creations Inc, Hudson, NC — Staffing Specialist and DCT 1998-2004 and 2011-2014

● Responsible for the staffing needs of 150+ clients including interviewing clients and prospective staff to match staffing needs.

● Helped implement policy changes as needed per state contracts.

● Worked one on one with special needs clients.

PROJECTS

Upgraded a Fill Line Built for Terminal Sterilization Products to Fill Aseptic Products This project provided redundancy for aseptic products. The aseptic filler for this building was aging and the project made it possible to upgrade the line without loss to production. The filler was upgraded to decrease batch run times by 30 to 50 percent depending on vial size. This project required additional restricted air barriers (RABs) to be designed to ensure vials were in a class 100 air supply through capping. The project came in under budget and was completed on time. The project was performed during a biannual shutdown. Install, HEPA certifications, calibrations of new photohelic gauges, and smoke studies were completed in less than 14 days. I personally oversaw this project along with the entire facility shutdown. Implemented A5 Gowning

The project eliminated gowning shortages, reduced costs, and improved quality. Traditional laundered gowns have an 8 week turn around to get new sizes or additional items in rotation. Staff turnover was a major issue which led to issues with this method. A5 gowns had a 4-day turnaround time. The notable reduction in cost was estimated to be greater than 35 percent, however total savings would be calculated after contract buyout. Microbiological counts related to gowning decreased by 85 percent with the use of A5 gowning. Installation of Photohelic Gauges in place of Magnehelic Gauges A CAPA was created in response to an investigation to address a Pureflow cart that had malfunctioned during use. The malfunction was discovered by QA personnel and it was unknown the amount of time the range was out of tolerance. I proposed a switch to photohelic gauges because they have set points to alarm if outside of tolerance.

EDUCATION

Bachelor of Science, Psychology with a concentration in Human Services Appalachian State University, Boone, NC

Associate of Arts

Caldwell Community College and Technical Institute, Hudson, NC PROFESSIONAL DEVELOPMENT

● “7 Habits of Highly Effective People” given by Ed Gash; NC BioNetwork; Lenoir, NC; April 2019

● “Management Essentials” given by Ed Gash; NC BioNetwork; Lenoir, NC; February 2019

● “Speed of Trust” given by Ed Gash; NC BioNetwork; Lenoir, NC; January 2019

● “Aseptic Processing” given by Rebel Umphlett; NC BioNetwork; Lenoir, NC; October 2018

● “Total Responsible Person” given by Butch Smith, CCC&TI; Lenoir, NC; October 2018

● “Good Documentation Practices” given by Andrew Capps, NC BioNetwork; Lenoir, NC; September 2018

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