Quality Control Assurance

Marianita Ravelo

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

Minneola, Florida 34715

Cell: 407-***-****

Email:****************@*****.***

Objective: Dedicated and dependable professional, seeking an opportunity that will

utilize my ability with over twenty five years of Quality Control Experience in

manufacturing.

12/2013 to Present

MedNap, LLC Brooksville, Florida

Quality Control Manager

• Effectively manage all fuctional areas and departments in opening a new

GMP company.

• Responsible for directing activities of the QA department to facilitate

business needs while maintaining quality standards

• Write and review qualification of validation documents including cleaning

CIP and COP

• Assure activities for final disposition decisions for quarantined or rejected

material of all types are made by QA. Assure that proper disposition

decisions are made and that all activities are properly documented and

performed in a timely manner.

• Assure that any technical complaint from end use customers or distributor

personnel is appropriately received, managed, resolved, and reported

• Assure completed production records are reviwed and released by QA prior

to distribution of finished products

• Proactively identify and align technical projects to resolve global quality

issues

9/2012- 12/2013

CelMark International. Orlando, Florida

Quality Control Microbiologist

• Monitored all microbiological activity on all incoming raw material

• Bulk product testing

• Water system testing experience.

• Environmental microbiological monitoring.

• Guaranteed a safe and stable finished product that will meet shelf life, will

not contain potentially harmful pathogen, and will be generally safe for

consumption.

• Monitored microbiological activity in finished ingestible and topical

products.

• Monitored air quality in manufacturing, packaging in the micro lab.

• Analyzed and report on all microbiological testing.

• Released finished goods from a mandatory quality hold upon attainment of

satisfactory results.

• Logging and tracking samples and chemicals

1/2012 – 8/2012

Genelink Biosciences Inc. Orlando, FL

Quality Manager.

Genelink Biosciences Company startup from ground zero.

Worked with all Documentation from completion of the Florida Department

License application requirements to Standard Operation Procedures (SOP)

c’GMP, forms, created Master Batch Record, work instructions.

Created and implemented all company policies and procedures.

Worked with the company Director to implement c’GMP compliance in order to

pass State requirements auditing for licensing.

Once completed with all the State requirements, went through the Florida

Department Business Audit and received licensing for the Company

production startup.

Lead and monitored the operational functions of the Quality Control.

8/2009 – 5/2011 Nephron Pharmaceutical, Orlando, FL

Senor, Quality Assurance.

Lead and monitored the operational functions of the Quality Assurance.

Responsible for batch record review, including formulation, micro.

Monitored all QA personnel activities, including all documentation review for

accuracy, completion Non Conformance Report.

3/2006– 6/2009 CEMEX Inc., Davenport, Florida

Personnel and Safety Director

Coordinated drug testing for all Operators and ensures all Documentation are

current.

Trained all Operators on safety rules and regulations to perform their work

duties as part of the orientation programs and periodical training for

effectiveness.

Participated in DOT (Department of Transportation) compliance audits and

retrieved all request associated with employee documentation.

6/1998-12/2005 Abbott Laboratories, Whippany, NJ

Quality Control (Supervisor)

Trained personnel on proper sampling, inspection, and testing of production

batches and ensured the accuracy and correctness of production samples and

paperwork per SOP (Standard Operation Procedures.)

Performed statistical sampling, inspection and physical testing on incoming

materials (raw materials, active ingredients, liquids, packaging components

and finished bulk tablets). Thorough Knowledge and use of Micrometers,

Calipers, Height Gauges. Color Charts and blue prints.

Performed AQL’s (Acceptance Quality Level) and in-process inspections in the

packaging area to assure conformance to SOP and cGMP standards.

Conducted daily release activities of various materials and components to

specified departments..

Conducted daily audits in the production areas (i.e., compression, granulation,

weighing, film coating) to ensure SOP’s and cGMP are being followed

Lead the operational functions of the Incoming Quality Control lab. Attend daily

Manufacturing meeting with upper management, to coordinate the daily

Manufacturing schedule

5/1986-9/1996 Roche Pharmaceutical Corp. Nutley, NJ

Packaging & Filling Room Supervisor

Attended daily Manufacturing meeting with upper Management and planners,

to coordinate the, daily Manufacturing schedule.

Monitoring of Personnel training and performance per SOP, c GMP.

Non Conformance Reports, Coordination and Monitoring of daily Activities of

the Packaging & a class 10,000 Filling Department.

Administered SOPs, and GMPs, including safety rules for clean room &

Packaging

Education

Berdan Institute (School of Medicine), Totowa, NJ -Medical Assistant Degree

Microbiology Laboratory Technician- Knowledge of FDA regulated company

requirement, USP 61, 62 standard. Experience in Microbiological sterile plating

techniques, High School Diploma, Word, Excel and Lotus Note, Bilingual.

Class 10,000 Sterile clean room (Certified). GMP, SAP, Process Pro.

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