Marjana Muskaj
Philadelphia,PA
Summary
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combine strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Strong background in developing and implementing quality control processes, conducting through inspections, and identifying areas for improvement. Valued team collaborator known for adaptability and reliable performance in dynamic environments. Proficient in utilizing advanced analytical tools and methodologies to drive results and enhance overall product quality.
Demonstrated ability to identify and resolve defects, contributing to improve manufacturing processes. Proven track records of using analytical skills and attention to detail to enhance product reliability and team efficiency.
Demonstrate strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Bring positive attitude and commitment to continuous learning and growth.
Overview
8
8
years of professional experience
Work History
Quality Assurance Document Control
Catalent Pharma Solutions
08.2022 - Current
- Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
- Review of material status, protocol conformance, clinical design layout and ensuring blinding techniques are followed.
- Monitor schedules for production priorities.
- Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.
- Confirm proper randomization schedule utilization for correct patient treatment group assignment.
- Communicate with clients for batch release.
- Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations and client requirements.
- Ensure timely release of batch for protocol initiation date.
- Release batch within scheduling database.
- Release batch within JDE inventory management system.
- Record and track errors and not-right-first-time to maintain departmental metrics.
- Archive batch documents onto shared drive and within archive room.
- Communicate SQDC countermeasures and safety issues to Quality Management.
- Ensure QADC metrics are met or acts to correct.
Quality Assurance Inspector
Catalent Pharma Solutions
03.2021 - 08.2022
- Ensured production standards met through thorough visual inspections and non-destructive tests.
- Facilitated issue resolution by reporting repeated problems to supervisors and collaborating departments.
- Communicated quality issues effectively with the production team to enhance product excellence.
- Established and maintained quality standards to ensure superior product output.
- Recommended process adjustments to improve efficiency and product quality during production.
- Trained production team on quality control measures to enhance overall product standards.
Production Line Worker
Catalent Pharma Solutions
07.2020 - 03.2021
- Follow safety protocols to prevent accidents and injuries to self and colleagues.
- Follow instructions to make products in line with customer specifications.
- Collaborate with other production workers to achieve smooth running of production line.
- Box, label, and transport items to support assembly operations.
- Inspect bottles for misalign closures, print registration and missing print copy, inspect seal integrity of pouch, print registration and missing print copy, inspect blister units and place them into properly assigned card locations for multi-fill operations; inspect blister cavities for missing product, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity.
- Inspect clinical labels at 100% accountability. Clinical labels can be either manually or automatically applied.
- Inspect sealed blister cards for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product.
- Inspect clinical vials, ampoules and syringes utilizing black and white light boxes.
- Cold storage packaging that also require working with cold product both outside and inside refrigeration conditions.
- Assembly work which includes utilizing barcode scanning equipment and computers.
Laboratory Technician Assistant
Intermedica
01.2018 - 01.2019
- Play an active role in troubleshooting technical issues related to equipment malfunction or procedural discrepancies within the laboratory setting.
- Assist in maintaining a clean and organized lab environment, ensuring accuracy and safety during experiments.
- Manage inventory of laboratory supplies, place orders when necessary to avoid stock shortages that could delay experiments or research projects.
- Receive, label and safely store samples to be tested.
- Determine and perform tests needed for the analysis and reports.
- Record tests and analyses and then report the results.
- Discuss and answer any questions regarding the results.
- Organize and store samples in accordance with all safety and other requirements to ensure the safety of personnel and integrity of the sample.
- Clean and maintain lab equipments, including recalibration of equipments.
- Maintain equipment records and daily work logs.
Education
Master of Science - Biology
University of Tirana
Albania, Europe07-2017
Bachelor of Science - Biology
University of Tirana
Albania, Europe07-2015
Skills
- Quality inspection techniques
- Team leadership
- Continuous improvement initiatives
- Quality control management
- Data analysis
- Problem-solving
- Critical thinking
- Attention to details
- Communication
- Documentation
- Adaptability
- Time management
- Collaboration
- Analytic reasoning
Timeline
Quality Assurance Document Control
Catalent Pharma Solutions
08.2022 - Current
Quality Assurance Inspector
Catalent Pharma Solutions
03.2021 - 08.2022
Production Line Worker
Catalent Pharma Solutions
07.2020 - 03.2021
Laboratory Technician Assistant
Intermedica
01.2018 - 01.2019
Master of Science - Biology
University of Tirana
Bachelor of Science - Biology
University of Tirana