16 years fda experience
Resume:
Bridget L .Grant
Lancaster, PA. 17603
************@*****.*** 717-***-****
My name is Bridget Grant. I am a versatile,skilled professional with
leadership qualities and experience. Possessing excellent hands on
experience developing and improving processes and operations. Assertive
associate with outstanding communication and people management skills, with
a strong background in production.
Black belt certified in LEAN Manufacturing. Exceeds in fast paced
production FDA and GMP Environment .Knowledgeable with manufacturing
processes from raw material to finished product.
Able to effectively communicate with at all levels of an organization. Due
to being a valuable employee in the past. I earned many promotions, and
greater job responsibilities. In addition I was the head member of the EHS
team for my department. I authored SOP's and gave presentations regarding
work related issues. Complies with and is knowledgeable with OSHA, FDA,and
GMP standards.
I am very interested in seeing what your company has to offer as well as
what I can bring to your company. I look forward to discussing my
qualifications with you in greater detail.
Thank you for your time and consideration.
Sincerely,
Bridget Grant
Education:
LEAN /Six Sigma Manufacturing Master Black belt Certification
Train the trainer Certification
Assets Business Management.
Belford High School. Diploma. GPA 3.1
Experience:
Glaxo Smith Kline Biologicals Quality Control Logistic Technician
/Quality Control Training Coordinator/ Position responsibilities
Sep.2007-Aug2013
Industrial Excellence- Lead numerous Lean/Six Sigma projects
Resulting in over $320,000 annual company savings. Created more
efficient processes for finished product .Core member of the Industrial
Excellence Team to structure new building design for multi-million
Dollar re-organization stricter of testing laboratories, warehouses
And office areas.
Training-Provided training tracking for site. Working with training
Department . Lead Various SOP, written and hands on training for
Managers,Supervisors, employees and contractors. Ensured employees
Maintained training requirements
Supervised contracted cleaning company- Provides feedback, schedules
Cleaning frequency, and order supplies needed. Provides documentation to
Track compliance, zone requirements, cleaning frequency, and proper aseptic
technic, was performed. Reviews weekly and monthly documentation, files
data..
FDA Audit Assistance-Key function for FDA audits. Contacts subject matter
experts,
Assist in coaching strategies, speaks with auditors to provide their
request. Escorts
Auditors to site locations, Provides feedback to departments of findings.
Attends audit
awareness preparation meetings to reconcile issues or findings
Safety Audits- In charge of all Q.C. Departments monthly safety audits.
Inspection of
Chemical storage, eyewashes, safety showers, product expiration, product
labels
Employee safety performance, ergonomical work area and tidy working
environment.
Q.C. Critical equipment contact- Primary contact for Alarm Management
System in order
to maintain compliance on a variety of critical product storage equipment.
Q.C. Inventory-Ordered and maintained stock items for all Quality Control
departments.
performed quality release on products.
Equipment Validation- Assisted in validating Q.C. equipment, machinery and
testing.
To ensure the integrity of the final product. Tracked, documented and
reviewed findings.
Supplier contact-Contact for several suppliers. Review weekly inventory,
receive deliveries
Communicates new or changing needs to supplier company. Answers questions
for orders.
Q.C. Laboratory equipment maintenance- Performs
weekly monthly and quarterly
Maintenance on Cryogenic tanks, incubators,
refrigerators freezers and water
bathes. Including checking fill levels, temperatures, sterility and product
configuration
are all within specifications. Assuring that valuable samples biologics,
and viruses are
properly stored. Document maintenance performed and condition or equipment.
Authors SOP's- Authored many standard operating procedures. Writes and
reviews SOP's used for training
processes.
Integrity testing- Performs weekly filter testing for sterilization and
decontamination autoclaves. Reviews
results of test, checks data against
passing result specification. Makes
copies and communicated results to QA
department for review and archive
results.
Autoclave Operator- Operates decontamination and
sterilization autoclave.
Take inventory to meet and supply sterilized
equipment for production needs.
Documents and reviews run cycle
data.
Turkey Hill Dairy Senior Freezer Production Operator-Controls
viscosity, ammonia levels, air intake and valves. CIP sanitation
procedures on various filler lines. Testing samples for sanitation
cycles. Assessment of inventory and stock for production.
Incorporates various ingredients for proper product quality.
Complies with OSHA and GMP standards. July 6 2004 to Sep07.
Kemps Foods. Quality Control Supervisor-Responsible for maintaining
quality of all of the products in the plant. Made sure everything
being produced was the expected weight, volume, temperature,
and have the right amount of ingredients necessary for a quality
product. Completed mix tracking assignments. September 2001-
September 2003.
Kemps Foods. Ammonia Freezer Operator/Break Relief-Controls
viscosity, ammonia levels, air intake and valves. Sanitized lines
when done running products. Kept track of stock and paperwork
for production line. August 2000-September 2001.
Kemps Foods. Fluid/Bottling Operator-Operating various lines
of bottling products. Changing over size specifications. Kept
products at set weight and volume. Supply stock for specific
production lines. Tracking inventory for quality assurance
records. September 1997-August 2000.
Kemps Foods. Packer-Packing products in corrugated boxes
assuring code was legible. Trained new employees. December
1996-September 1997.
References: Tricia Zimmerman-QC logistics manager at Glaxo Smith Kline
Crystal Eberly Leader man at Turkey Hill Dairy717-***-****
Delisa Ernest-Nurse at Calvary Home
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