Michelle L. Primm
Bedford,IN
Summary
Reliable individual with skills in leadership, primary manufacturing, and quality assurance. Expert in leading and coordinating with others on various projects. Dedicated to working until projects are completed and meeting the highest standards. Right the first-time attitude.
Overview
8
8
years of professional experience
Work History
Housing Supervisor
Indiana University
08.2024 - 07.2025
- Schedule, assigns, and monitors work of custodial workers and/or moving and setup workers for the needs of the day.
- Take inventory of supplies and places orders as necessary to maintain stock levels.
- Serve as an on-site trainer to explain work procedures and to demonstrate use and care of all cleaning equipment.
- Act as a project leader for routine and non-routine work.
- Reviews and executes work under orders.
- Guides the work of moving and setup workers in preparation for conferences, meetings, and events happening on campus.
- Acts in relief of custodial workers, performing custodial duties as needed.
- Operating passenger vehicle to transport mobile crew/equipment to various sites.
Quality Representative
Catalent Pharma Solutions
12.2022 - 06.2024
- Quality Assurance Representative has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, customer complaints and shipping.
- Responsibilities included (but not limited to): review batch documents, assist with revision of GMP documentation, initiate deviations as required, provide dedicated quality floor oversight of GMP operations for manufacturing and drug substance, perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedure and Good Documentation Practices, and supports client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
Value Stream Supervisor
Catalent Pharma Solutions
10.2021 - 12.2022
- Managed the day-to-day activities and employees within the Primary Manufacturing.
- Ensured that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
- Constantly evaluated the internal processes and procedures and worked to create an efficient primary manufacturing area while maintaining the highest possible quality.
- Responsibilities included (but not limited to): presenting and defending policies and procedures, proactively investigate and evaluate the latest policies and procedures, evaluate employees, submitted time for employees, written or verbal communication for employees, ensure compliance with safety guidelines and proper operating parameters, and approved time off for employees.
Equipment Lead_ Syringe Line 1
Catalent Pharma Solutions
08.2020 - 11.2021
- An Equipment Lead’s primary responsibility is to efficiently and safely setup and operate the various pieces of production equipment within the facility.
- The equipment lead is expected to work in a hands on fashion, to take ownership of the quality and quantity of product produced during shift and to be actively involved in continual process improvements.
- Responsibilities include (but not limited to): Follow accurately all GMP documents (Batch records, SOPs, protocols, etc.), operate in a clean room environment within required gowning, aseptic behaviors, and proper flow procedures, assist manufacturing personnel to identify and eliminate waste, implement standard-work, and provide problem solving and solutions, must adhere to company compliance and safety, advise management on proposed corrective actions, safely operates complex equipment in accordance with cGMP’s, assists in onboarding of new employees and supports maintenance/engineering teams during repairs and upgrades.
Manufacturing Associate
Catalent Pharma Solutions
03.2019 - 08.2020
- A manufacturing associate is responsible for leading daily production activities in accordance with Good Manufacturing Practices (GMP).
- Accountable for final formulation and filling for the manufacture of biopharmaceutical products under cGMP.
- Performs media simulation runs of processes as needed to ensure they are appropriately aseptic.
- Responsibilities include (but limited to): perform processing steps and/or manufacturing support activities, monitoring process against the batch record, support aseptic filling process for products and use automated filling equipment in an aseptic manufacturing environment, and documents cGMP data and information for processing steps and/or equipment activities, following standard operating procedures.
Department of Child Services Family Case Manager
State Of Indiana
11.2017 - 03.2019
- Protect children from abuse and neglect, maintain and reunify families whenever possible and locate a permanent home or independent living when needed for children unable to be reunited with their families.
Education
Medical Insurance Specialist Program -
Northwest Career College
Las Vegas, NV08.2015
Bachelor of Science -
University Of Phoenix
Las Vegas, NV06.2007
Skills
- Management
- Human Resources
- CLIA Regulations & Inspections
- Deviations
- OSHA Regulations
- Review of GMP
- Review of Batch Records
- Quality Assurance
Timeline
Housing Supervisor
Indiana University
08.2024 - 07.2025
Quality Representative
Catalent Pharma Solutions
12.2022 - 06.2024
Value Stream Supervisor
Catalent Pharma Solutions
10.2021 - 12.2022
Equipment Lead_ Syringe Line 1
Catalent Pharma Solutions
08.2020 - 11.2021
Manufacturing Associate
Catalent Pharma Solutions
03.2019 - 08.2020
Department of Child Services Family Case Manager
State Of Indiana
11.2017 - 03.2019
Medical Insurance Specialist Program -
Northwest Career College
Bachelor of Science -
University Of Phoenix
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