QA/Production Manufacturing

Carmen M. Rodriguez

Mobile Phone: 813-***-****

E-mail: *****************@*****.***

CAREER PROFILE

Seeking a position to exercise my knowledge experience in Quality Control inspector and document control and audit processes regulations and guidelines, Standard Operating Procedures (SOP); excellent interpersonal and problem-solving skills able to work under pressure, with minimum supervision; Ability to plan coordinate and perform multiples tasks simultaneously proficiency in office equipment, documentation related to materials, knowledge of plotter drawing equipment Business Administration.

PROFESSIONAL EXPERIENCE

VistaPharm Pharmaceutical Industry Largo, Florida February 2017 to Oct 2017 Lead Line Production

Ensure that all current Good Manufacturing Practices (cGMPs) and SOPs are adhered to related to the equipment, work area, and personnel.

Check quality of packages being packed, Check quality of packaging components. Ensure proper counts of packages and finished goods, place label and product information and specially with the liquids that are noncartic. Perform all retaping of reinspected goods. Repack all rework cases as required, Load skids with finished product keep work area clean and orderly.

Maintain sanitary practices when handling product or components. Attend training sessions to maintain and increase knowledge of the current Good Manufacturing Practices (cGMPs) and Safety Awareness, Assist in the checking-in and accountability of packaging components. (Temporary Assignment)

Catalent Pharmaceutical Industry Clearwater, FL June 2015 to December 2015 Documentation Specialist

Engineering Department

Reviewing documents Maintenance Work Orders entering in JD Edwards for grammatical and technical flow, and for conformity to departmental standards and file them. Create documents from start to finish ensuring they meet Quality standards, coordinate changes to engineering documents.

Control of standards and customer documentation, serve as a resource to company personnel to allow appropriate access to documents including retrieval and photocopying/scanning of documents as requested. Coaching R&D staff on ways to improve their writing competencies as well as edit, clarify and proofread documents. (Temporary Assignment)

ION Pharmaceutical Industry Clearwater, FL October 2014 to April 2015 Quality Control Inspector

Maintains quality standards by approving incoming materials Collagen Powder, natural weight loss capsules and liquids energy drinks and Hydrocox, tablets vitamins and Viagra, also packing animals vitamin.

Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.

Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor.

Approves finished products by confirming specifications; conducting visual and measurement tests; returning products for re-work; confirming re-work.

Documents inspection results by completing reports and logs; summarizing re-work and waste; inputting data into quality database.

Keeps measurement equipment operating by following operating instructions; calling for repairs maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.

Accomplishes quality and organization mission by completing related results as needed. Analyzing Information Reporting Research Results, Documentation Skills, Promoting Process Improvement, Safety Management, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation. (Temporary Assignment)

Peak Nutritional Products LLC Tampa, FL April 2014 to Sept 2014

Quality Auditor

Provide quality support for the manufacturing, production lines, packaging and shipping department by performing inspections and weight of the product energy shots and the liquid flavors (Vipe) for the electric cigarettes. Auditing document follows pertinent SOPs to ensure cGMP compliance. (Temporary Assignment)

Macy’s Corporation Clearwater, FL Oct 2011 to Jan 2013

Customer Service Bilingual

Answering telephone calls in English and Spanish from customers and Associate of the stores of Macy’s regarding the status of merchandise and other service issues providing information and giving orientation the customers about their orders and giving the customer the maximum service and assistant. Assist customers with returns of merchandise, placing orders for the customer, tracking the delivering dates, putting data in the system of programs ICM and Main Frame.

Warner Chillcott Pharmaceutical Fajardo, PR Sept 2008 to April 2010

Quality Inspector

Packaging Department

Process of packing tracks cards fillers machines of inspection, cardboard sealing machine of packing birth control pills in “Blister” etc. Handling of the materials, receipt, cleaning, storage, labeled, weighed and manufactures managing documents to work with the procedures for environmental sampling, trade, inspection, tests, monitored, qualification and validation, approval of the product, among others. Responsible of monitored all the variables that can affect the end item that fulfilled its standards of quality.

Becton & Dickinson Pharmaceutical Las Piedras, PR April 2008 to August 2008 QA Documentation Assistant /Specialist

Assure documents are correct, efficient and effective analyze and ensure MR’s, IMW verifying documents in SAP and QDMS adding any revision surgical blades of al size that requires the customer. Create SMP’s documents for all areas; ensure all documents meet FDA, and all other agencies regulatio

ns standards and other projects as assign. (Temporary Assignment)

Becton & Dickinson Pharmaceutical Las Piedras, PR Sept 2006 to August 2007

Laboratory Documentation Coordinator

Coordinates and assists inspections by regulatory agencies, such as CAP. Responsible for facilitating any required documentations, renewals and any other inspection-related activities.

Coordinates the proficiency testing activities by facilitating the subscription of required proficiency testing materials, ensuring testing the needles all sizes are performed and the results are submitted in a timely manner.

Ensures that appropriate follow up on corrective action is implemented when test result/s is found unsatisfactory. Has primary responsibility for the planning, development and standardization of the Safety Manuals, Chemical hand hygiene Plan, Exposure Control Plan and Infection Control Plan consistent with the requirements of OSHA

Monitors laboratory staff in regards to issues related to health and safety and notifies supervisory staff of any problems to ensure compliance with safety policies and procedures.

Serves as a source of reference for regulations pertaining to laboratory safety, chemical hygiene and safe disposal of chemical and biohazardous materials.

QA Manager, supervisors and other staff in coordinating QA activities of the labs.

Maintains up-to-date knowledge and understanding of requirements and regulations follow up and maintenance of analytical research and development documentation ability to solve problems and identify solutions effectively Knowledge and understanding of the processes, methods and operations in functional area(s) of responsibility Knowledge of computer systems and software used in functional area. (Temporary Assignment)

EDUCATION

Bachelor Degree Administration

Columbia College University Caguas, PR

Associate Degree in Administrative Assistant

Humacao Community College Humacao PR

Certification Pharmaceutical Quality Inspector

Advance Professional Development Center Caguas, PR

SKILLS

JD Edwards

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MR Procedures,Traceability Standards, Testes, AQL Ruler Procedure,

Quality Systems FDA Regulations and cGMP, GMP

SAP Program

Documentum (QDMS)

Knowledge in GDP, SOP’s and Safety (OSHA)

Responsible, Dynamic

Confidential

Computer Literate: XP MS Office, Microsoft Word 7.0, Excel

Knowledge management of plotter drawing equipment

Bilingual: (English and Spanish)

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