Runellie del C.

Ortiz Rivera
Cond. Estancias del Rey Apto 708 Caguas, Puerto Rico 00725
(787) 317-4584 / (787) 839-3947 ro693374@westpost.net

OBJECTIVE
A position in a Quality department within a high profile company where my people
management, analytical and results oriented talents can be effectively utilized
to improve and contribute company goals.
SUMMARY OF QUALIFICATIONS
A skilled professional with leadership qualities and excellent hands-on experien
ce in quality operations and people management with 10 years of experience in th
e Pharmaceutical Industry. Professional with a master degree in Chemistry with
five years of supervisory experience. Strong experience in laboratory investiga
tions, NOE's, CAPA'S, change controls, QC data review, audits, Stability guideli
nes, protocols and Annual Product Reviews. Strong knowledge of cGMP's, Good Doc
uments Practices, cGLP's, OSHA, and FDA regulations. Strong knowledge in the us
e of HPLC, UV, dissolution equipment and Karl Fisher, Millennium and Chemstation
data software. Certified in Supervision and Management and Lean Six Sigma Gree
n Belt. Computer literate (Word XP, Excel, PowerPoint). Bilingual in English an
d Spanish.
PROFESSIONAL EXPERIENCE
BIOVAIL LABORATORIES, Dorado, PR 2001 - Aug 2009

QC Supervisor- Finished Product and Stability Area (2006 - 2009)

Supervised and coordinated daily work schedules and oversee daily routine depart
ment activities of 7+ employees. Reported directly to the QC Manager. Responsib
le of coordinating and performing laboratory personnel training's. Strong expe
rience in the development of complete and concise laboratory investigations base
d on scientific judgment including NOE's. Responsible of the documentation and
follow up of corrective and preventive actions (CAPA). Assured compliance of
Q.C. Laboratory with Regulatory Agencies. Executed performance evaluation and
established disciplinary action plans. Experience in change controls of proced
ures (QC and QA). Experience in Stability guidelines, protocols and annual prod
uct reviews.
Selected Accomplishments:
Participated in the implementation of the MFG/ QAD System by performing the sy
stem validation and preparing the SOP, which allowed the employees to enter the
dissolution data results directly into system ensuring an errors free job.
Increase Laboratory cycle time of Finished Goods lots from 85% to 99% with coo
rdination of daily work through laboratory schedule.

Senior Laboratory Analyst- Stability & Finished Product Area (2002 - 2006)
Responsible for supervision and coordinating daily work schedules and oversaw da
ily routine department activities of 10+ employees under the direction of the QC
Manager. Developed complete and concise laboratory investigations based on sci
entific judgment. Responsible of coordinating and performing laboratory personn
el training's. Ensured compliance of QC Laboratory with Regulatory Agencies.
Reviewed data and authorized re-test. Released lots according to metrics targe
ts.
Selected Accomplishments:
Awarded as Biovail Employee of Month August 2004.
In charge of coordination of laboratory tasks of both work groups as acting- S
upervisor.

Laboratory Analyst - Stability Area (2001 - 2002)

Responsible for calibrating, testing and operating laboratory instruments such a
s HPLC, GC and Dissolution Apparatuses. Scheduled and performed stability sampl
e and raw materials test in compliance with the cGMP standards. Responsible fo
r maintaining all SOP's and investigation reports up to date. Trained new perso
nnel in HPLC techniques.

KELLY TEMPORARY SERVICES, Guayama, PR 1998 - 2001

Company: WYETH PHARMACEUTICALS, INC., Guayama, PR
QA Laboratory Analyst (1999 - 2001)
Packaging Operator (1997 - 1999)
Company: BAXTER CARIBE, INC., Guayama, PR
Chemical Operator (1998)
IPR PHARMACEUTICALS, Guayama, PR 1996
Chemist (Internship)

EDUCATION
Catholic University of Puerto Rico, Ponce, PR 2010
MS in Chemistry
University of Puerto Rico, Rio Piedras, PR 1998
BS in Science

CERTIFICATIONS
Lean Six Sigma Green Belt
Supervision and Management

TRAININGS
Good Manufacturing Practices, Good Documents Practices, Laboratory Safety Securi
ty Rules, Hazard Communications, Respiratory Protection, Personal Protective Equ
ipment, Supervisory Skills, How to handle and conduct effective laboratory inves
tigations reports as per FDA Compliance, Technical writing and Lean Six Sigma.

AFFILIATIONS
Active member of the Puerto Rico College of Chemists, Chemist Licensed since 200
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