Margaret Bakalarz
Hillsboro,OR
Summary
I am a highly experienced Quality Assurance Professional with a passion for ensuring top-notch manufacturing quality. With over 24 years of industry experience, I have worked in various roles including Quality Lot Release, Supplier Audit, and Manufacturing Operations. My expertise in manufacturing quality has been honed through a range of staff positions held within the pharmaceutical industry.
Overview
25
25
years of professional experience
Work History
Lot Disposition QA Specialist III
HTO/Genentech
Hillsboro, OR
03.2022 - Current
- Perform batch disposition activities for products manufactured at Genentech Hillsboro OR facility following established processes and procedures, performance metrics and adherence to schedule.
- Ensure that the batch disposition process meets required standards via cross functional collaboration at the site and with the global Roche/Genentech network.
- Support tech transfer activities related to Lot Disposition.
- Support APQR and APDR.
- Support Health Authority inspections as needed and follow up on any corrective measure.
- Attend regular meetings with cross-functional teams to discuss project progress updates.
- Contribute ideas for improvement in existing QALD processes based on industry best practices.
- Provide technical guidance and mentorship to junior members of the MQA team when needed.
- Collaborate with management to discuss effective plans for resolving major quality problems.
Frontline/Backline MQA Specialist III
HTO/Genentech
Hillsboro, OR
01.2017 - 03.2022
- Performed QA oversight, and reviewed documentation associated with batches produced at HTO to ensure operations were performed to comply with cGMPs, SOPs and Quality Standards.
- Acted as a critical Quality contact to manufacturing for divination management, batch record review, and line support to ensure site's Right to Operate.
- Supported HTO Product Complaints as Lead Investigator to meet on time closure goal.
- Streamlined complaints investigation process by leveraging Backline MQA capabilities and allowing for faster turnaround of the investigation actions.
- Trained and coached newer MQA specialists through the quality decision making process.
QA Specialist II/III
Roche Carolina, Inc.
Florence, SC
03.2014 - 02.2017
- Performed lot disposition activities for products produced at RCI following established procedures and adherence to schedule.
- Performed and documented discrepancy trends and/or continual improvement analysis with the generation and/or approval of associated reports.
- Participated in the external supplier audits.
Manufacturing Shift Leader
Roche Carolina, Inc.
Florence, SC
03.2005 - 03.2014
- Ensured staff was properly trained on all aspects of their job duties, including safety protocols.
- Monitored employee performance to ensure compliance with company policies and procedures.
- Assisted in training new employees on shift operations.
Manufacturing Process Technician
Roche Carolina, Inc.
Florence, SC
03.1999 - 03.2014
- Understood and followed oral and written directions.
- Demonstrated leadership by making improvements to work processes and helping to train others.
Education
Associate of Science - Medical Laboratory Technology
Medical Professional College
Kielce, Poland05-1985
Skills
- Quality Management Systems
- cGMP regulations
- Analytical Thinking
- Sound Decision-Making Abilities
- Release Squad team member
- MELODI Existing User team member
- HTO DS/DP team member
- 2021 ICP Graduate
- 2019 QDP Graduate
Timeline
Lot Disposition QA Specialist III
HTO/Genentech
03.2022 - Current
Frontline/Backline MQA Specialist III
HTO/Genentech
01.2017 - 03.2022
QA Specialist II/III
Roche Carolina, Inc.
03.2014 - 02.2017
Manufacturing Shift Leader
Roche Carolina, Inc.
03.2005 - 03.2014
Manufacturing Process Technician
Roche Carolina, Inc.
03.1999 - 03.2014
Associate of Science - Medical Laboratory Technology
Medical Professional College