Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Else Bielarski

Ballston Spa,NY

Summary

Recent Biology graduate with 2 years of QA/QC experience in a cGMP laboratory, seeking to contribute expertise to quality systems within the pharmaceutical industry. Strong skills in SOP writing and reviewing, batch record review, and basic equipment maintenance and calibration.

Overview

5
5
years of professional experience

Work History

Server

Morrissey's Lounge and Bistro
09.2024 - Current
  • Explained menu items and suggested appropriate options for food allergy concerns.
  • Worked with the POS system to place orders and manage bills.
  • Served food and beverages promptly with focused attention to customer needs.

Quality Analyst II

Bionique Testing Laboratories LLC
02.2024 - 05.2024
  • Coordinator of test record review to manage the distribution of documentation for timely review and transmission to clients.
  • SME for Compendial Method Testing (CMT) and Advanced Compendial Molecular Testing (ACMT).
  • Support the Routine Testing Group process improvement initiatives.
  • Support User management, onboarding, and training in ZenQMS.
  • Conduct internal audits and communicate areas for improvement to the directors of the Routine Testing Group, R&D, and Quality.


Quality Analyst I

Bionique Testing Laboratories LLC
09.2022 - 02.2024
  • SME for certificate of analysis transmission to clients.
  • Coordinator of all Routine Testing and R&D equipment maintenance, qualification, and validation activities.
  • Author and reviewer of BTL documents, including batch records, SOPs, and associated quality documents.
  • Assist internal audits for Routine Testing and R&D laboratories to ensure compliance with GMP and identify areas for improvement.
  • Support the Associate Director of Quality with hosting customer audits and regulatory inspections.
  • Support investigations (LIR/ER/IR).
  • Support the review of URS/Change Controls.

Genetics and Cell Biology Tutor

Paul Smith's College
01.2021 - 12.2022
  • Developed and executed daily lesson plans to engage and challenge student understanding and involvement.
  • Created skill-based assessments to test student mastery of required skills of focus.


Quality Intern

Bionique Testing Laboratories LLC
05.2022 - 09.2022
  • Support the creation, approval, and distribution of BTL's controlled documents.
  • Coordinate the archival and maintenance of BTL's controlled documents.
  • Support the transmission of certificates of analysis to clients.
  • Coordinated the creation of new logbooks for all site equipment and laboratories.
  • Supported continuous monitoring for critical laboratory spaces.

Education

Bachelor of Science - Biology

Paul Smith's College
Paul Smiths, NY
08-2025

Skills

  • Experience in cGMP
  • Risk Management and Audit Preparedness
  • SOP writing
  • CAPA implementation
  • Batch record review
  • ALCOA

Accomplishments

Designed and implemented a comprehensive equipment tracking spreadsheet to monitor maintenance schedules for all BTL equipment and laboratories; improved visibility and compliance with regulatory requirements across departments.


Led company-wide Quality Systems training to enhance employee understanding of ALCOA+ principles and best documentation practices; strengthened data integrity and compliance across all departments.

Timeline

Server

Morrissey's Lounge and Bistro
09.2024 - Current

Quality Analyst II

Bionique Testing Laboratories LLC
02.2024 - 05.2024

Quality Analyst I

Bionique Testing Laboratories LLC
09.2022 - 02.2024

Quality Intern

Bionique Testing Laboratories LLC
05.2022 - 09.2022

Genetics and Cell Biology Tutor

Paul Smith's College
01.2021 - 12.2022

Bachelor of Science - Biology

Paul Smith's College

Similar Profiles

CREATE PROFILE