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Senior manufacturing associate skills for your resume and career
15 senior manufacturing associate skills for your resume and career
1. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Interfaced with internal stakeholders and third-party vendors to plan GMP material activities to support Manufacturing.
- Assist materials management with organization and inventorying of GMP Cell manufacturing materials.
2. Cell Culture
- Authored and revised several Standard operating procedures for campaigns in Cell culture operations.
- Coordinated production operations for up-stream cell culture manufacturing area
3. Lean Six Sigma
- Delivered 2% water usage savings in a treated water efficiency project as a Lean Six Sigma Kaizen Leader.
4. Harvest
- Completed CIP and SIP of bioreactors, harvest transfer lines and chromatography skids.
- Perform purification operations of the harvest using an automated production DeltaV program.
5. CIP
A Capital Improvement Plan (CIP) is a planning tool used to coordinate the timing and financing of capital improvements over a period of several years. It helps organizations make good budget decisions for large projects and purchases based on objectives and resources. The purpose of a CIP is to identify capital improvement projects, identify and forecast funding sources, prioritize improvements based on available funds, and estimate a timeline for completing the improvements.
- Performed commercial CIP, SIP, Pack or Unpack 60cm, 120cm, and 160cm columns using Delta V system.
- Performed pressure test, CIP, and SIP operations of cGMP equipment.
6. Production Equipment
Production equipment in limited terms is used to define any type of machinery or equipment used in the production of a video or film. Basic production equipment includes a camera, tripod, lighting kit, camera light, short term microphone, light reflector, boom pole, shock mount, audio cables, wireless microphone, headphones, portable digital audio recorder, camera lenses, extra batteries, external hard drive, and DSLR shoulder mount rig.
- Measure and record data associated with production equipment.
- Led shift in operation of production equipment, including cleaning, sterilization, and process operations.
7. Process Equipment
Process equipment refers to the machinery used in processing and refining industries. This equipment is responsible for a single job in the refinement process, which can vary from maintaining the flow of a chemical, controlling chemical reactions, or even storing chemicals. Process equipment can also be broken down into two categories, which are fixed and rotating equipment, depending on the movement required from the equipment.
- Train new team members in the use and function of all process equipment and safety guidelines.
- Batch Record Review (BRR) and log review for process equipment.
8. Lean Manufacturing
- Generate and implement ideas for Operational Excellence in Manufacturing (Six Sigma / Lean Manufacturing).
- Lead continuous operational improvements for the department using Kaizan and lean manufacturing principles.
9. Bioreactors
- Assembled, prepared, sterilized, inoculated, monitored and decontaminated bioreactors.
- Performed manual operation and/or programming of 50 liter, 200 liter, 1000 liter and 2,000 liter bioreactors.
10. MES
- Experienced with LIMS, SAP, Maximo, Citrix, Trackwise, MES and GLP/GMP production.
- Co-developed MES System requirements across multiple companies within corporation.
11. Aseptic Processing
- Produced sterile compounds and performed aseptic/fill/seal and sterile filtration in aseptic processing facility.
- Lead other Cell Processing Associates during aseptic processing of clinical and commercial products using SOPs.
12. SME
The term ‘small and medium-sized enterprises' is meant to describe businesses of varied sizes who fall below certain limits and targets set by various organizations, such as the World Bank and the UN. SMEs, as they are commonly known, are an important part of any economy and generally, in healthy economies, should vastly outnumber other forms of business, such as multi-level corporations, because they collectively employ more people, pay better, and produce more money.
- Subject Matter Expert (SME) for INOVA and TL Filler.
13. Troubleshoot
Troubleshooting is the process of analyzing and fixing any kind of problem in a system or a machine. Troubleshooting is the detailed yet quick search in the system for the main source of an issue and solving it.
- Support Process Development activities in executing and evaluating processes, troubleshoot problems, and documenting result.
- Participated in engineering runs to troubleshoot and streamline process in preparation for production manufacturing.
14. Media Preparation
- Performed buffer / media preparation, fermentation, acid/base chemistry.
- Performed sampling/in-process testing to support manufacturing and validation testing Media Preparation and Reagent Preparation.
15. CAPA
- Propose corrective action for Quality incidents (CAPA).
- Lead and supported Deviation, CAPA investigations, Change Requests Developed and authored protocols and reports for projects/process changes.
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List of senior manufacturing associate skills to add to your resume
The most important skills for a senior manufacturing associate resume and required skills for a senior manufacturing associate to have include:
- GMP
- Cell Culture
- Lean Six Sigma
- Harvest
- CIP
- Production Equipment
- Process Equipment
- Lean Manufacturing
- Bioreactors
- MES
- Aseptic Processing
- SME
- Troubleshoot
- Media Preparation
- CAPA
- Clinical Trials
- Technical Reports
- FDA
- Sigma
- Production Schedules
- Clean Room Environment
- Corrective Action
- Delta
- Autoclaves
- QA
- MPS
- Lims
- Manufacturing Support
- Data Analysis
- Buffer Preparation
- Laboratory Equipment
- QC
- Critical Processes
- Routine Functions
- Regulatory Compliance
- Column
- Safety Regulations
- TrackWise
- Uf/Df
- Environmental Monitoring
- HPLC
- Cleaning Validation
- Syringes
- Centrifuges
- Inventory Control
Updated January 8, 2025