Grace Mary Glowka MT(ASCP)

** ****** ******

Doylestown, PA

267-***-****

adpkvy@r.postjobfree.com

SKILLS SUMMARY:

Quality Control Pharmaceutical: Raw material testing and release. Microbiology USP testing,

environmental monitoring, water collection and testing, equipment

maintenance, calibration and validation, laboratory supervision,

customer audits, cGMP, HACCP.

Clinical Laboratory: Phlebotomy, manual testing procedures, automated equipment use, maintenance,

calibration and validation, laboratory inspection preparation, MT(ASCP).

Group Exercise/Fitness Training: Group class programming, group exercise class instruction,

individual fitness training, small group training, AFAA, NASM, TRX,

Mad Dogg.

CLINICAL/PHARMACEUTICAL EXPERIENCE:

Society Hill Reproductive Medicine – Philadelphia, PA

May 2020 to May 2021

Andrologist/Phlebotomist – Medical Technologist

Responsibilities:

1Perform all duties in the Andrology laboratory including: semen analysis, sperm freeze, specimen preparation for donor insemination and Intrauterine insemination, receipt and storage of donor sperm from outside cryobanks, according to current WHO procedure guidelines.

2Perform phlebotomy duties to obtain proper patient blood samples for in house analysis and outside testing.

3Perform serum analysis in the endocrinology laboratory, using the Beckman Coulter Access 2 analyzer.

4Perform startup, maintenance, troubleshooting and shutdown of Beckman Coulter Access 2 analyzer.

5Perform daily quality control and inventory maintenance in the Andrology and Endocrinology laboratory.

6Provide inventory support, clean and sterilize exam instruments, clean patient exam rooms, maintain donor storage tanks.

Penn Fertility Care –Philadelphia, PA

May 2018 to February 2019

Andrologist- Medical Technologist

Responsibilities:

7Perform all duties in the Andrology laboratory including: semen analysis, sperm freeze, specimen preparation for donor insemination and Intrauterine insemination, receipt and storage of donor sperm from outside cryobanks, according to current WHO procedure guidelines.

8Perform serum analysis in the endocrinology laboratory, using the COBAS e411 analyzer.

9Perform startup, maintenance, troubleshooting and shutdown of COBAS e411 analyzer.

10Perform daily quality control and inventory maintenance in the Andrology and Endocrinology laboratory.

Colorcon -West Point, PA

May 2008 to November 2017

Senior Microbiologist-Quality Control

Responsibilities:

1Manage one to three direct reporting employees in the Quality Control Microbiology laboratory.

2Provide training and guidance for laboratory employees.

3Perform all Microbiological testing for raw materials, lakes and finished products according to current USP Harmonized specifications.

4Write and revise procedures as changes are necessary.

5Initiate all Microbiology laboratory out of specification investigations.

6Interact with customers during audits and product investigations.

7Provide support to research and development and Quality Assurance, for microbial issues.

8Provide guidance to production areas when cGMP and Microbiological issues/contamination occurs.

9Member of HACCP Team.

10Member of HAZWOPER emergency spill team.

Merck and Company-West Point, PA

May 2007 to May 2008

Associate Manager Raw Materials Planning and Release

Responsibilities:

1Manage five direct reporting employees including: 3 material planners, 1 material release coordinator, 1 material testing coordinator within Biopharmaceutical Clinical Supplies and Technology.

2Provide raw material planning and release support for new clinical supply campaigns.

3Interact with clinical supplies manufacturing groups, buffer and media preparation support groups, quality assurance and quality control departments.

BioRexis Pharmaceutical Corporation-King of Prussia, PA

August 2004 to March 2007

Senior Quality Control Microbiologist/Quality Control Manager

Responsibilities:

1Start new Microbiology laboratory, including; purchase of large equipment, special equipment, reagents and media.

2Write and perform procedures for quality control assays, including; bioburden, endotoxin, reagent and media qualification, organism identification, environmental monitoring, water testing, gowning and material handling in GMP areas.

3Provide Quality Control Microbiology/Chemistry support for GMP operations by performing all assays requested for in-process and final product testing.

4Perform regular environmental monitoring and water sampling and testing for GMP operations and laboratory areas supporting GMP operations.

5Report to Director of Quality.

6Supervise Quality Control Microbiology and Chemistry department.

7Member of the GMP training committee for employee training seminars.

8Initiate all OOS investigations for Quality Control department.

9Initiate or assist in manufacturing deviation investigations.

10Review all Quality Control data generated in Microbiology, Chemistry and Raw Materials testing.

Neose Technologies, Inc. – Horsham, PA

April 2002 to April 2004

Senior Quality Control Microbiologist / Quality Assurance Analyst

Responsibilities:

1Microbial identification using the BBL Crystal System, Bioburden, Heterotrophic Plate Counting, Media Qualification, Endotoxin Determination by KQCL, Environmental Monitoring, Water Collection procedures, and Cell Bank testing for bacterial viability and fungal viability and spore titer.

2Responsible for Environmental Monitoring plan, including facility start-up and scheduled monitoring, for new pilot plant.

3Procedure and protocol writing, review, and revision and QA/QC collaboration for many pilot plant programs.

4Member of the quality team for company wide GMP training.

5Product Batch Record review for QA release.

GlaxoSmithKline – King of Prussia, PA

January 1994 to April 2002

Quality Control/Assurance Specialist August 2001 to April 2002

Responsibilities:

1Batch record review for bulk product release.

2GMP training presentations for gowning, cleaning, environmental monitoring.

3Internal auditing of Cell Banking, Fermentation and Purification.

4GAP analysis of biopharmaceutical quality systems and SOP revision and review.

5External raw material and contract laboratory auditing.

Senior Quality Control Microbiologist February 1998 to August 2001

Responsibilities:

1Microbial Identification using Vitek ID system, Bioburden, Heterotrophic Plate Counting, Media Qualification, Endotoxin Determination by KQCL, Environmental Monitoring and Water Collection procedures for WFI, WDI, and Clean Steam sites.

2New employee training including: bench instruction for assays performed in QC Microbiology, general cGMP education, and training documentation.

3Responsible for department operations in the absence of the Microbiology supervisor.

Raw Material Coordinator January 1994 to January 1998

Responsibilities:

1Receipt, inspection and sampling of all raw materials and components used in GMP Biopharmaceutical operations.

2Performed most identity and use assays (USP, FT-IR, and special) for raw materials, documenting all sampling and test results, maintaining inventory and documentation of Raw Material Archive samples.

3Supervised training for Assistant Quality Control Biochemist (for raw material control duties), assay qualification, assay development, procedure and specification revision and initiation, vendor audits, and assay transfer to bulk pharmaceutical plant.

4Performed the duties of Raw Material Analyst and Biochemistry Analyst within Raw Material Quality Control.

Clinical Laboratory Technologist June 1983 to January 1994

Rolling Hill Hospital- Clinical Chemistry

Presbyterian Hospital- SmithKline French Clinical Research Unit

Methodist Hospital- Clinical Microbiology, Clinical Chemistry

FITNESS/GROUP EXERCISE EXPERIENCE:

Health Fitness- Johnson & Johnson Corporate Fitness (Horsham, PA/Springhouse, PA)

May 2019 to Present

Fitness Instructor / Fitness Trainer

Responsibilities:

1Create and lead group exercise classes: HIIT, Strength Training, TRX Suspension Training. Provide one on one personal training for employees to maintain healthy lifestyle.

Cornerstone Health and Fitness/Doylestown Fitness Center – Doylestown, PA

March 2019 to Present

Fitness Instructor / Fitness Trainer

Responsibilities:

1Create and lead group exercise classes: HIIT, Strength Training, Cardio Kickboxing, Indoor

Cycling, TRX Suspension and Bootcamp classes. Demonstrate proper technique by queing and physical demonstration.

Philadelphia Sports Clubs- Chalfont, PA

December 1998 to March 2013

Group Fitness Instructor / Personal Trainer

Responsibilities:

1Instruct group fitness classes, including; Cardio Kickboxing, Strength Training, Indoor Cycling, Step, Pilates Mat and Pilates Reformer, Zumba.

2Provide personal training services to clients.

Education:

Thomas Jefferson University - Philadelphia, PA

Bachelor of Science - Medical Technology – 1983

Temple University – Ambler, PA

Courses: Quality Assurance in Research and Development

Good Manufacturing Practices

SAI Global- Colorcon Onsite Training

Course: Intermediate HACCP- 2013

Food Innovation Center, Rutgers- Colorcon Onsite Training (20 hours)

Course: Hazard Analysis & Critical Control Point- 2015

Professional Associations:

American Society of Clinical Pathologists - Associate Member since 1983- MT(ASCP) #153179

Certified Spinning Instructor (Mad Dogg) – since March 1999

Certified Group Exercise/Fitness Trainer (AFAA)– since 2000

TRX Certified Instructor (TRX) – since 2009

Personal/Volunteer Associations:

Women Bike Doylestown – since 2015

Cat Tales Rescue (Animal Lifeline)– since 2016

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