JORDAN ALECTRO
Cromwell
Summary
Highly skilled Chemsitry Quality Assurance Specialist with a comprehensive understanding of QA methodologies along with laboratory experience. Possess strong analytical skills, and the ability to identify risk ensuring compliance with quality standards. Success in implementing effective QA strategies that have improved operational efficiency. Skilled at fostering positive relationships with team members to ensure project success.
Overview
5
5
years of professional experience
Work History
Chemistry Quality Assurance Specialist
Current Position
06.2023 - Current
- Issued and reviewed executed batch records for clinical, validation, and training purposes.
- Perform real-time review of executed batch records and release of radiopharmaceuticals for human use.
- Supported the environmental monitoring oversight of the GMP lab
- Review analytical data reports for batch release.
- Verify lists of in-use components and equipment.
- Assisted in the document control of SOPs and WIDs tracking, review, and finalization.
- Participated in internal and sponsor audits
- Track OOS/deviation findings, and report noticed trends to the supervisor.
- Maintain current documentation of training and certifications for chemistry and chemistry QA.
- Review change control documents, and approve changes to systems and equipment belonging to the Chemistry department.
- Review technical reports, such as for accurate transcription of data.
- Knowledge in CFR Title 21, Part 211, and 212.
- Conducted risk assessments and CAPAs to identify potential quality issues, and developed mitigation strategies.
- Assisted in the development and validation of testing methods for radiopharmaceuticals.
Quality Assurance Associate-Contract
3M
Stafford Springs
01.2023 - 05.2023
- Performed analytical testing such as Endotoxin (LAL), ICP of filter media samples
- Issue, review, and release of batch records.
- Aided in inventory management, ordering lab supplies to ensure operations.
- Scheduling preventative maintenance activities for laboratory instruments.
- Prepared samples for analysis by weighing, filtering, or diluting them as needed.
- Utilized aseptic techniques to prevent contamination and ensure the integrity of samples.
- Assisted in the troubleshooting and repair of laboratory equipment, minimizing downtime and ensuring continuous operation.
Scientist I -Contract
Boehringer Ingelheim
Ridgefield
09.2021 - 01.2023
- Managed the logistics of test items and vehicle diluent in a GLP setting.
- Coordinated shipments and communicated with international import compliance to contract research organizations
- Performed periodic checks of inventory records and updated expiry dates to ensure records were accurate based on certificate of analysis
- Aided in organizing documentation for QA audits and FDA inspections
- Provided access to archived materials through both physical and digital means.
- Prepared recordkeeping systems and procedures for archival research and for retention or destruction of records.
Laboratory Technician/Sample Management- Contract
Charles River Laboratory
New Haven
09.2020 - 09.2021
- Authored, reviewed, and maintained SOPs
- Oversaw lab equipment stock and placed orders to expand inventory.
- Utilized Laboratory Information Management Systems (LIMS) for tracking, documenting, and reporting laboratory activities.
- Ensured that all laboratory areas were kept clean and orderly at all times.
- Gathered biological samples for laboratory tests.
Education
Bachelor of Science - Biology
Eastern Connecticut State University
Willimantic, ConnecticutSkills
- Batch record review
- Environmental monitoring
- Analytical testing
- Document control
- Change control
- Risk assessment
- GMP compliance
- Laboratory management
- Inventory management
- Attention to detail
- Quality assurance
- LIMS Software
- HPLC, GC, ICP, LAL, and MCA analysis
- Aseptic techniques
- Audits
References
References available upon request.
Timeline
Chemistry Quality Assurance Specialist
Current Position
06.2023 - Current
Quality Assurance Associate-Contract
3M
01.2023 - 05.2023
Scientist I -Contract
Boehringer Ingelheim
09.2021 - 01.2023
Laboratory Technician/Sample Management- Contract
Charles River Laboratory
09.2020 - 09.2021
Bachelor of Science - Biology
Eastern Connecticut State University
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