Joslenny Garcia
Tobyhanna ,PA
Summary
Experienced professional with a strong background in the pharmaceutical and biotechnology industry. Proven track record of meticulously inspecting and ensuring product quality. Dedicated to maintaining high standards and attention to detail, resulting in consistently meeting regulatory requirements and exceeding customer expectations. Seeking a challenging position to leverage skills and expertise for making a meaningful impact on the success of a dynamic organization.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Azzur Labs
11.2023 - Current
- Ensures incoming materials meet quality standards before use
- Supports internal audit processes
- Assists in investigating deviations and client concerns in the laboratory
- Manages training records and documents
- Reviews various documents, including raw data, reports, logbooks, quality control records, and quality assurance records, for accuracy and compliance with guidelines and regulations
- Ensures proper control of laboratory testing as required for review
- Maintains knowledge of laboratory testing procedures
- May draft or review client notifications for exceeded levels
- Collaborates on implementing, maintaining, and improving quality systems
- Stays updated on industry standards and technological developments by reading standards, journals, and publications
Incoming QA Inspector
Thermofisher
01.2022 - 04.2023
- Conducted approval of specifications and incoming inspections on materials
- Assisted in day-to-day issues, including improvement initiatives and root cause investigations for nonconforming issues
- Performed material and process inspections and samplings
- Communicated with customers and project managers regarding materials, inspections, and specifications
- Reviewed logbooks for proper documentation, entry errors, and neatness
QA inspector
Piramal Critical Care
02.2021 - 12.2021
- Conduct inspections every 30 minutes checking for any major or minor defects on the product
- Batch record review and also printing out the batch records
- Use SAP(Trackwise) for inventory and Ensur to print batch records
- Use Excel to log and keep track of batch records
- Verify the accuracy, completeness, and support documentation of the packaging requirements outlined and ensure all are supported by the appropriate documentation within the batch record
QC inspector
Sharp Clinical
02.2020 - 12.2020
- Report findings for in process errors and provide follow ups to ensure adequate completion of corrective actions
- Perform document review of compounding activities such as cleaning records, line clearance, and inventory sheets
- Conduct audits on production line on a daily basis
- Take retain samples of the product
- Perform hourly inspections to ensure product has no defects or misinformation
- Perform leak and torque testing on packaging of product (blister cards, pill bottles)
QA inspector
Sharp Packaging
07.2018 - 01.2020
- Responsible to ensure and enforce GMP compliance, performing quality inspections to ensure batch record documentation is accurate (lot numbers, expiration dates, item numbers, calibration due dates, asset numbers)
- Review records corresponding documentation for additional requests along with memos, deviations, change controls, etc
- Accountable for performing quality inspections as required per batch record, AQL requirements, and verification of challenges
- Collect retain and customer samples as well as beginning, middle, and end samples
- Knowledgeable in controlled drug for primary and secondary and shift reconciliations
Filling Production Technician
Sanofi Pasteur
05.2015 - 04.2018
- Operate production lines with SOP and SWI
- Ensure the completion of sampling and corresponding documentation as required by cGMP
- Follow effective procedures to ensure production of a safe efficacious product, along with helping maintain positive working relationships between all team members
- Follow Standard Operating Procedures (SOP) and batch records (BR) to produce commercial drug substance material
- Setup, cleaning, sterilization, and use of manufacturing equipment in the cGMP commercial manufacturing
- Works to complete quality documentation (BPR’s, logbooks, etc.) accurately in a timely manner
- Ensures completion of sampling & corresponding documentation as required
- Ensures materials required for production are available as needed
- CFR (code of federal regulations) / PAI inspection readiness
- FDA audit understanding and awareness
Education
Highschool diploma -
Stroudsburg Highschool
Stroudsburg, PA06.2013
Skills
- Detail Oriented
- Quality Assurance
- Problem-solving skills
- Analytical Thinking
Certification
- Filing line clearance
- SAP barcoding
- Tank check(s)
- Aseptic technique and gowning qualifications for filling operations
- Disposal of hazardous materials
- Basic cleaning/disinfection L1, L2, and L3 for grades A/B and also C/D areas
- Environmental monitoring
- Equipment operations
Timeline
Quality Assurance Specialist
Azzur Labs
11.2023 - Current
Incoming QA Inspector
Thermofisher
01.2022 - 04.2023
QA inspector
Piramal Critical Care
02.2021 - 12.2021
QC inspector
Sharp Clinical
02.2020 - 12.2020
QA inspector
Sharp Packaging
07.2018 - 01.2020
Filling Production Technician
Sanofi Pasteur
05.2015 - 04.2018
Highschool diploma -
Stroudsburg Highschool
- Filing line clearance
- SAP barcoding
- Tank check(s)
- Aseptic technique and gowning qualifications for filling operations
- Disposal of hazardous materials
- Basic cleaning/disinfection L1, L2, and L3 for grades A/B and also C/D areas
- Environmental monitoring
- Equipment operations
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