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16 years fda experience

Location:
Lancaster, PA
Salary:
50000
Posted:
September 03, 2014

Contact this candidate

Resume:

Bridget L .Grant

*** **** ***** **. ****

Lancaster, PA. 17603

acfqex@r.postjobfree.com 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

717-***-****

Crystal Eberly Leader man at Turkey Hill Dairy717-***-****

Delisa Ernest-Nurse at Calvary Home

717-***-****



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