Erica Edwards

Manufacturing Operations Leader for Formulations and Aseptic/Terminal Sterilization Filling.

· Lead operations team of 200+ colleagues to meet process and production demands.

· Responsible for sterile filling operations in various technologies and configurations.

· Direct day-to-day operations for short-term and long-term strategies to achieve business plan and profitability goals.

· Resolve problems proactively and decisively, applying business acumen and sound judgment.

· Aide senior leadership during executive decision-making process by generating daily reports to recommend corrective actions and improvements.

Leader in R1/R2 PreOps for Centralized Drug Weigh, Formulations, Equipment/Commodity Preparations.

• Directed the organization's daily operations, ensuring compliance with applicable procedures and regulations.
• Identified opportunities for improvement in operational performance metrics.
• Coordinated resources across departments to maximize productivity levels.
• Cultivated stronger relationships with Filling customer by responding promptly to concerns and requests.

Leader in Technical Sterility Service department focusing on improvement projects and activities related to aseptic processing.

· Managed team of Aseptic Process Engineers.

· Responsible for implementing best aseptic practices including the media fill program, smoke studies, wrapping strategies for aseptic equipment, isolator glove integrity.

· Liaised with Manufacturing, Quality, Biological Quality, Regulatory, and Engineering groups within the Pfizer network to ensure compliance alignments with PQS's, cGMP, and industry requirements.

Leader in Technical Sterility Services department focusing on contamination control in the clean rooms supporting aseptic filling operations for the Rocky Mount site.

· Manage diverse staff totaling over 40 exempt and non-exempt personnel.

· Identify and implement improvements/best practices related to cleaning techniques to reduce and eliminate contamination in classified and controlled unclassified areas of aseptic facilities.

· Work cross-functionally with internal and external partners to ensure site alignment with industry guidelines and Pharmaceutical Quality Systems (PQS).

Core team member of corporate cross-functional group responsible for providing support to start-up of newly constructed >$250MM aseptic/terminally sterilized small volume parenteral manufacturing facility in Vizag, India.

· Worked on teams for Compliance Remediation and Technical Transfer of manufacturing processes and analytical test methods for >70 product molecules from US sites to Vizag.

· Identified and remediated compliance gaps for Rocky Mount manufacturing site as part of product transfer.

· Wrote and assembled change control packages for remediation and product transfer to Vizag.

· Reviewed regulatory submission packages for products in scope of Project Dolphin.

Pioneered this newly created role for Hospira Rocky Mount as the first hire to pilot site leadership efforts to collaborate improved relations between manufacturing operations and quality and embark on site-wide remediation and modernization projects for Rocky Mount.

· Created, managed, and developed team of 6 exempts (Aseptic/TS Core Monitors, Supervisor) and 26 non-exempts (Environmental Cleaning Specialists)

· Provided support in planning and execution of media fills for 5 conventional aseptic and 2 isolator filling lines

· Troubleshot issues related to environmental monitoring and media fill simulation excursions

· Led the following projects for continuous improvements: Plant Captive Gowning; Plant Disinfectant/Efficacy Study; Sticky Mat Placement Throughout Plant; Continuous Particulate Monitoring On-line System; Camera and Cleanroom Phone Installation in Aseptic Filling; Improvements to Aseptic and Media Simulations

Site microbiologist who provided guidance to manufacturing, quality, and validation departments on aseptic processing, cleaning, microbial testing, and investigations related to environmental monitoring program.

· Managed staff of 4 exempts (Supervisors) and 23 non-exempts (Lab Technicians) in Environmental Control Lab, Data Analysis, and Media Prep Lab.

· Performed tracking and trending of environmental data to help reduce excursions.

· Identified and implemented CAPAs to promote improved aseptic techniques and behaviors.

· Provided oversight as biology expert in launch of newly constructed manufacturing aseptic and terminally sterilized filling areas: Part-Fill, VISIV, SVP TS Filling Line 198, and SVP Aseptic Line 105.

Provided quality oversight for floor operations of all business units at R1 and R2. Performed batch record review and release of product.

· Supervised staff of non-exempt personnel consisting of Quality Controls Operators and Batch Record Auditors.

· Identified solutions to quality issues related to the manufacturing process of finished product goods.

· Monitored compliance within facility SOPs, cGMPs, and corporate specifications.

Temporarily filled role of Manufacturing Supervisor in SVP Aseptic Filling to gain experience in Operations based on career growth plan.

· Supervised a non-exempt staff in the aseptic filling department ensuring practices and behaviors were performed in alliance with proper aseptic technique and cGMP.

· Met critical production schedules to meet volume and reduce downtime.

Coordinated chemical analytical testing for in-process, final product, and stability drug formulation methodologies for routine sampling and product complaint samples.

· Gained experience in testing such as HPLC Chemstore, Atomic Absorption, Automatic Titrating Systems.

· Audited chemical batch records and data for product release and special projects.

Conducted bench testing for product and water samples.

· Performed bacterial endotoxin testing

· Performed Heparin potency testing