LINDA J. HERNANDEZ

**** ** *** ******* *********: 954-***-****

Miramar, FL 33025 Cell: 954-***-****

abmred@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Detailed oriented, reliable and organized Quality Professional with

extensive experience in fast paced, deadline oriented and quality focused

manufacturing and packaging environment. Possesses excellent analytical

and observation skills. Reputation as subject matter expert, with strong

background in Current Good Manufacturing Practices (cGMP) with special

emphasis on Quality Systems. Key strengths include:

Team Leader / Player Problem Solver Process Improvement

People Oriented Documentation / Fully Bilingual English /

Systems Development Record-Keeping Spanish

Diligent Work Ethic Customer Oriented

PROFESSIONAL EXPERIENCE

NATURE'S PRODUCTS INC, Sunrise, FL

2009- Present (Nature's

Products Inc. is a global contract manufacturer and packager of consumer

healthcare products)

Quality Assurance & Quality Control Director

Managed and coached top performing team of twenty professionals.

. Led implementation of Quality Systems to assure all requirements were

met according with the 21 CFR Part 111

. Designed and conducted GMP trainings for all plants employees

resulting in full understanding of regulatory compliance.

. Successful reorganized Quality Assurance, Regulatory, Compliance and

Laboratory Testing departments which identified opportunities to

improve efficiency and customer service.

. Developed and implemented SOPs.

. Significantly increased customer base and sales revenue within one

year by implementing Supplier Qualification Program, Internal Audit

Program, Stability Program and Non-conformance process.

SCHERING-PLOUGH, Miami Lakes, FL 2004 - 2008

(An innovation-driven, science-centered global health care company with net

sales of $18 B.)

Quality Assurance Manager

Managed and coached top performing team of five professionals. Organized

and prioritized monthly closing to assure all deadlines were met in a

timely manner. Reviewed and approved Standard Operation Procedures (SOPs),

equipment, facility, process changes, validation protocols and summary

reports. Managed material disposition for incoming material, intermediates

and finished goods and Customer Complaints Program.

. Successfully reorganized Quality Assurance department which identified

opportunities to improve efficiency and customer service.

. Reduced site deviation rate by 35% by utilizing SIP methodology and

identifying root causes.

. Effectively implemented monitoring program for Manufacturing and

Packaging Operations.

. Led implementation of Deviation Management and Corrective Action and

Preventive Actions (CAPA) system in Trackwise.

. Developed mechanism which reduced timeframe for batch record review

process by 30%.

. Won first place in Miami Lakes Site and second place in the Right

First Time Excellent Award in the Regional Division.

. Facilitated and provided guidelines which identified root causes and

preventive actions.

ARNET PHARMACEUTICAL, Davie, FL 2003 - 2004

(Internationally recognized contract manufacturer of complete range of

vitamins, minerals amino acids and herbal supplements.)

Regulatory Affairs, Manager

Managed Laboratory Testing, incoming material sampling, in-process testing,

and material disposition with nine direct reports. Organized and

prioritized monthly closing, ensuring all deadlines were met. Escort

regulatory agencies (FDA, MCA and TESD) and Customer Inspections.

. Reorganized Quality Assurance and Laboratory Testing departments which

identified opportunities to improve efficiency and customer service.

. Developed and implemented SOPs.

. Ensured compliance with formula and supplements facts by thoroughly

reviewing and approving printing material.

. Identified the need to create Customer Complaint Program, developed

and implemented the program which facilitated investigations and

follow up.

. Significantly increased customer base and sales revenue within one

year by implementing Supplier Qualification Program, Internal Audit

Program, and Non-conformance process.

REXALL SUNDOWN, INC. / NBTY, INC., Boca Raton, FL 1998 - 2003

(Global vertically integrated manufacturer, marketer and distributor of

broad line of high-quality, value-priced nutritional supplements in the

United States and throughout the world. net sales of $2 B.)

Quality Assurance & Compliance, Manager

Built and managed team of six top performing professionals. Managed all

Compliance functions for Manufacturing and Packaging Operations at Rexall

Sundown division. Escort regulatory agencies (FDA, MCA and TESD) and

Customer Inspections.

. Established and selected team work for Compliance department.

. Developed and implemented SOPs.

. Implemented Supplier Qualification Program which steamlined vendors

selection process.

. Effectively implemented Customer Complaints Program, Non-Conformance

and Change Control Processes.

. Assigned responsibilities of material disposition for the finished

goods in the absence of QA Manager.

. Played instrumental role in identifying root causes and preventive

actions in the investigation process by providing guidelines and

working in collaboration with all departments.

EDUCATION / CERTIFICATION

Master of Business Administration (MBA), University of Phoenix, Guaynabo,

P.R.

Bachelor of Science (BS), Chemistry, University of P.R., Cayey, P.R.

Train the Trainer Certification, Quality Auditor Certification, Hazard

Analysis Critical Control Point Certification

TECHNICAL SKILLS

Computer Software: MS Word MS Excel, MS Power Point, MS Outlook, Trackwise,

Documentum, AS400, Isotrain.

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