aseptic processing operator resume example with 4+ years of experience
An Aseptic Manufacturing Professional with 4 years working in the biopharmaceutical industry. Proficient in Aseptic techniques in sensitive ISO based environments. A focused, detailed oriented, and dedicated professional, committed to the quality of product delivered to patients when processed within the aseptic environment. Extensive experience executing full lifecycle GMP clinical and commercial drug product manufacturing. Proficient with MES electronic batch record data entry system to record data in real time while executing processes. Proficient with Laboratory Information Management System (eLIMS) for storing data such as cell counts, crucial time data and/or quantity number of vials stored physically. Analytically strong and organized, willing to pitch in whereever needed and take the initiative to get things done. Able to work independently as well as a collaborative member of a team.
- Proficient In the practices of aseptic techniques
- Experience with MES an Electronic batch record to execute processes, eLIMS, SAP, and Trackwise
- Time management, Organization, Interpersonal, Commitment, Communication
- Trustworthiness & Ethics, Teamwork, Leadership, Problem solving, Urgency
- Willingness to learn
- Attention to Detail
- Sterilization Procedures
- Critical Thinking
- Fluent in Spanish
- Active Listening
- PPE Use
- ALCOA Principles
- Veeva Proficient
- Truevault Proficient
- Microsoft Office
- Basic Math
Burgettstown, PA, 08/XXX2 - 10/XXX2
- Involved in the processing for Gene Therapy products for use in clinical trials
- Involved in engineering runs, APQs, and in GMP readiness
- Responsible in reviewing all documentation including Batch records and Logbooks in āReal Time and Right First Timeā and demonstrate error free documentations
- Immediately reports any error or deviations noticed to management
- Obtaining equipment and raw material for manufacturing and compounding
- Ensure that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
- Execute all aspects of GMP clinical drug product manufacturing including, but not limited to sampling, compounding, and packaging
- Support warehouse operations including material sampling, production preparation, and cycle count support.
- Lead, verify, and execute manufacturing runs in sporadic business hours to meet our clients needs.
City, STATE, 03/XXX1 - 07/XXX2
- Perform process unit operations (i.e Cell culture, purification, and aseptic processing) according to SOP and batch records, while recording production data and information in a clear, concise format.
- Performing tasks in a consistent manner with safety policies, quality systems, and cGMP requirements
- Support the development of manufacturing processes, and willingness to work with others to drive continuous improvements and efficiencies within cell therapy technical operations
- Reviewing and verifying manufacturing procedures and batch records
- Real time review for all documentation and reporting
- Contributes to APS runs to ensure CGMP-compliance through quality and documentation
- Support in regulatory inspections and audits by ensuring inspection readiness within the facility
- Advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
- Working with SAP to create manufacturing goods, work orders, and take out supply when being used to keep our inventory up to date in our SAP system.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
City, STATE, 03/2019 - 02/XXX1
- Aseptic manufacturing of tissue-based products for the regenerative market
- Observe and monitor the quality of raw finished goods following SOP, GDP and GMP standards
- Operates heat sealers, biohazard laminar flow hoods, bar code scanners, aspiration systems, weighing scales and orbital shakers
- Document information and real time review of batch records on the manufacturing floor.
- Proficient in continuous improvement and improves efficiency and productivity within the group or individually.
- Maintained inventory of processing supplies.
- Recorded information on batch records, equipment and cleaning logs, and other sensible documents in real time.
City, STATE, 11/2017 - 02/2019
- Responsible for providing supplemental benefits to all union-based workers
- Developing and implementing affordable life insurance packages based on age, need, and income
- Meeting with families individually to explain how the benefits that are offered to them will help give them a secure future.
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Resume Overview
School Attended
- FAIRLEIGH DICKINSON UNIVERSITY
Job Titles Held:
- Aseptic Processing Operator
- CAR-T Operations Associate
- Manufacturing Technician
- Union Benefits Representative
Degrees
- Bachelor of Arts (B.A
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