A passionate Quality Assurance Supervisor with skills in process improvement, lean initiatives, team building and effective leadership. Focused on using training, monitoring and morale-building techniques to maximize employee engagement and performance.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Quality Assurance Supervisor
MilliporeSigma (Cell Marque)
07.2023 - Current
Responsible to lead and develop a group of Quality professionals to support and enhance our QMS
Provide technical and quality leadership and guidance to internal and external stakeholders in the achievement of a compliant Quality Assurance System
Provide technical support to internal and external customers in the achievement of product and process quality and, as appropriate, communicates with the Site Quality and Senior Management any potential product deficiencies
Provide Investigative and CAPA support by identifying, reducing, and controlling system and process defects as reported through the site Internal Audit Management System
Oversee site Audit and Supplier Quality program activities
Responsible through effective oversight and maintenance to ensure the Quality Management System conforms with requirements in the ISO/MDSAP, EU IVDR, FDA etc
Responsible for Orientation, GMP and GDP training for all the new hires in manufacturing, production, and quality departments
Provided training and workflow support/prioritization for direct reports in Quality Assurance
Wrote and revised Quality Standard Operating Procedures as needed
Proactively identified risks through activities including trending of non-conformance events, audit findings, self-inspections, and lab records/data review
Positive attitude and mindset, respective to others, infectious engrained team building drive
Curious, hungry for knowledge, and a drive to succeed: individually and as a team; willingness to learn and lead by example
Very trainable.
QC/QA Laboratory Manager (Production and Bottling)
LangeTwins Winery and Vineyard
02.2021 - 04.2023
Responsible for all laboratory functions for both production and bottling Lab QC
Responsible for hiring, training and managing lab technicians level I,II,III including harvest interns with analysis including but not limited Alcohol, Titratable Acidity, pH, Malic Acid, Residual Sugars, Volatile Acidity, Lactic Acid, Hot stability, Cold stability, Free and Total SO2, Ammonia, NOPA, Copper, Potassium, Pectin/ Glucans, Dissolved Oxygen and CO2, Turbidity, Bentonite trials, Acid trials, CMC trials, barrel fermentation monitoring, and bench trials/stock solution preparation for winemaking
Established a successful quality control program matching ETS Laboratory reproducibility
Established lean testing parameters for the winemaking team for all the stages of wine production and bottling, increasing efficiency and reducing redundant testing
Provided fiscal budget projection for lab parts/repairs, lab chemicals and equipment and personnel
Coordinated with vendors as needed for equipment repairs, PMs and out-sourced calibrations
Assisted in investigation of non-conformances related to bottling Quality Control and implemented Corrective and Preventative actions
Streamlined communication and collaboration between winemaking, Labs, Cellar and bottling team with continuous process improvement efforts
Defined priorities, delegated tasks and planned workflow for laboratory personnel
Developed short term and long term projects for Lab technicians
Reviewed employee performance and provided ongoing feedback and coaching to drive performance improvement
Performed trend analysis projects to better understand outliers and gaps in the processes
Participated in Safety Committee meetings and interfaced with EH&S team to oversee lab safety including safe handling/disposal of chemicals and biohazard reagents, enforcing laboratory and company safety policies
Ensured all quality control procedures and documentation are in compliance and up-to-date with internal SOPs and external regulatory guidelines such as TTB (Alcohol and Tobacco Tax and Trade Bureau)
Planned and executed different team building activities to build mutual trust and establish group values
Remained calm and professional in stressful circumstances and effectively diffused tense situations
Attended trade shows and visited other wineries to stay up-to-date on new technologies in the industry
Achieved TTB Certification.
Production Laboratory Lead
LangeTwins Winery and Vineyard
06.2017 - 01.2021
Performed analysis including Alcohol, Titratable Acidity, pH, Malic Acid, Residual Sugars, Volatile Acidity, Lactic Acid, Hot stability, Cold stability, Free and Total SO2, Ammonia, NOPA, Copper, Potassium, Pectin/ Glucans, Dissolved Oxygen and CO2, Turbidity, Bentonite trials, Acid trials, CMC trials, barrel fermentation monitoring, and bench trials/stock solution preparation for winemaking
Collected, labeled and stored lab samples according to laboratory specifications
Scheduled juice and wine analysis based on the stage of production and work orders performed by the cellar team
Performed data review and data entry in AMS
Assisted with smoke-taint bucket fermentation project
Performed crush field sample testing for vineyards for harvest readiness
Equipment troubleshooting and new equipment validation
Took initiative and provided direction and training to the lab staff
Created and updated SOPs as needed
Cross-trained with bottling line Quality control laboratory
Method development and validation to bring Copper, potassium, glucans, lactic acid and water-bath heat stability testing in-house for cost saving
Assisted with smoke-taint bucket fermentation project
Generated custom client reports for MOX monitoring and EOM wine chemistry
Monitored and reviewed lab supplies to ensure adequate inventories and continuous operation
Assisted with laboratory annual budgeting
Trained the cellar staff at harvest for Pectin/Refractometer testing and documentation
Researched new technology related to laboratory analysis.
QC Associate I
Genentech Inc.
04.2015 - 04.2017
Hands on Time Validation Project for Lean Initiative including Raw materials, In-process, Site and Network, and final product testing laboratories
Attended meetings to update planners on different issues with Raw Materials
Performed Raw Material Testing per USP, EP and JP compendia
Attended team GEMBAs and communicate scheduling issues
Reported end of the month Metrics
Planned and scheduled incoming Raw Material Testing per SOPs
Identified discrepancies and gaps in systems
Monitored testing procedures to meet established item specifications, standard test methods or protocols
Performed Sample Management functions with proper chain of custody
Prepared reagents for QC Labs per USP, EP and JP compendia
CCP2 –Manufacturing Sample receipt room setup.
Microbiologist I
Siemens Healthcare Diagnostics
01.2012 - 01.2015
Assisted with conducting routine microbiological testing including sub-culturing for organisms
Panel and inoculum preparation
Instrument maintenance (Walkaways) and operation
Data processing, visual interpretation of colorimetric reactions and AST results
Reagents and raw material testing
Data review and release of product.
Quality Control Technician II
S.K. Foods
01.2004 - 01.2009
Monitored tests and procedures for bacterial growth in tomato paste and various canned products including salsa, enchilada sauce and diced jalapeno
Calibrated and maintained laboratory equipment
Ran HPLC to analyze the scoville units of Peppers and assign them as mild, medium or hot
Made agar media, autoclaved it and poured plates for microbiological testing
Ran BacT alert sample on each lot of tomato paste
Provided quality support to ensure that products met quality standards and customer requirements.
Education
Bachelor of Science - Biological Sciences And Emphasis On Microbiology
University of California
Davis, CA
Skills
Quality Assurance
Process Improvement
HACCP
Corrective and Preventative Action
Decision-making
Customer Service
Employee supervision
Organizational skills
Analytical and Problem Solving
Method Validation
Communication
Lean Initiatives
Cross-functional team leadership
Microsoft Office
Certification
TTB Certified Chemist
Continuing Education
Hematology
Medical Microbiology
Immunology
References
References Available upon request
Languages
Urdu
Full Professional
pashto
Elementary
Hindi
Full Professional
Timeline
Quality Assurance Supervisor
MilliporeSigma (Cell Marque)
07.2023 - Current
QC/QA Laboratory Manager (Production and Bottling)
LangeTwins Winery and Vineyard
02.2021 - 04.2023
Production Laboratory Lead
LangeTwins Winery and Vineyard
06.2017 - 01.2021
QC Associate I
Genentech Inc.
04.2015 - 04.2017
Microbiologist I
Siemens Healthcare Diagnostics
01.2012 - 01.2015
Quality Control Technician II
S.K. Foods
01.2004 - 01.2009
Bachelor of Science - Biological Sciences And Emphasis On Microbiology