GIDALSY M.

RIVERA HERNANDEZ
E-mail:
434-229-4676 cell
163 Massena Dr. Apt 103
Lynchburg, Virginia
OVERVIEW
Obtained a Master in Microbiology in 1994 and worked in the pharmaceutical indu
stry for over 14 years in sterile manufacturing and dry product. Experienced (as
graduate work*) in methods to isolate genomic DNA; DNA amplification by PCR; So
uthern Blot hybridization; and non-radioactive method (ECL) for DNA labeling.
*G. Rivera, A. Rodriguez, P. J. Santiago Borrero, and C. L. Cadilla (1998) Beta
globin haplotypes in Puerto Rican subjects with sickle cell trait. Nucleic Acid
Symposium Series: Miami Nature Biotechnology Short Reports, vol. 9, p. 67-68, O
xford University Press.
Have a demonstrated record of growth in Document Control and Quality Assurance
operational matters in one of the largest pharmaceuticals in the industry (Eli L
illy).
Experienced in operational variety of fields such as: Microbiology lab; Raw and
Packaging Material
releases, SOP, training and Batch Records revision and filing; Equipment Qualifi
cation; Medial Fills
Validation; Water Systems Validation and Monitoring; Environmental Monitoring (R
CS);
Deviation, Change Control, CAPA, Vendor Qualification for Raw and Packaging Mate
rials,
Experienced with systems such as Trackwise, Regulus, Master Control, DMS, Pengui
n and Admin
Lims.
EXPERIENCE C.B. Fleet Laboratories Lynchburg, VA
Document Systems Specialist, 2008- Present
* Responsible to develop and review of SOPs; Trainings; Policies; Analysis Repo
rts; Specification documents; Batch Records, and assure they comply with the rec
ords management requirements.
* Work with the subject matter experts of Quality; Engineering; Production; Mai
ntenance and Microbiology-Chemistry Laboratory to review the current process and
regulations. Act as a Technical Writer for new SOPs.
* Edit the controlled documents to update the new/revised processes. Assure the
correctness of the design, templates and format.
* Implement and distribute the updated document to the affected areas. Responsi
ble of assure that any change to regulatory requirement/commitment being impleme
nted is reflected in the applicable documents in a timely manner.
* Planning and coordinating the distribution of documents relating to the areas
according their activities, and functions
* Coordinate the life cycle for records review and archival;
* Identify documents affected by changes in regulations;
* Lead and coordinate the collaboration meetings and assure the appropriate tra
ceability of the records lifecycle.
* Responsible of assure that any change to regulatory requirement/commitment be
ing implemented in other centers and sites are harmonize globally in the applica
ble documents in a timely manner.
* Review of quality control; quality assurance; Document Systems procedures and
reports, as required.
* Responsible of Master Control document System for the electronic review and a
pproval of GMP documents.
* Planning the activities related to Trainings required due to controlled docum
ent revision.
EXPERIENCE Florida Blood Centers Orlando, Fl
Validation Specialist/Technical Writer, July 2007- July 2008
* Responsible of the qualification/validation protocols and creation of SOPs an
d required for the implementation for new equipment.
* Responsible of assure that any change to regulatory requirement/commitment be
ing implemented is reflected in the SOPs in a timely manner.
* Responsible of the evaluation and revision of procedures used in Components a
nd Distribution, and ensure its compliance as per AABB and FDA standards;
* Responsible for SOPs upload to Smart Doc/ Pilgrim;
* Execute equipment and vendor qualifications including Temp Guard, Compomat G4
, rotators and freezers;
EXPERIENCE Lilly Del Caribe, Inc.
All the following positions were at Eli Lilly, Carolina PR since 1994 to 2007
Microbiologist, July 2007
* Responsible to determine and revise the SOPs affected with the Change Proposa
ls in progress including any revision requirement for SOPs resulted from Pharmac
opeias changes;
* Responsible for the evaluation of the utilities used in manufacture (Water sy
stems; Compress Air; Environmental Monitoring);
* Responsible for technician's responsibilities by the coordination and evaluat
ion for the systems monitoring program;
* Part of the Microbiology Team for all duties related to laboratory such as:
* Investigations for SARE in Track-wise using CAPA
* Preventive Maintenance assurance; equipment re-qualifications;
* Support for new equipment implementation (V-tech);
* Environmental Monitoring data evaluation;
* In Admin/Lims: Lot entry; Tests verifications, specification and method revis
ions etc.
QA/QC SOP Specialist, 2003-2007
* Responsible for the evaluation of the annual SOPs and trainings revision used
in Quality Assurance and Regulatory Central Unit according policies and Quality
Standards;
* Responsible for advice for SOP content tied to regulatory commitments related
to location; sizes; process; equipment; laboratory; utilities or any other oper
ation that needs to be evaluated for modification through a Change Proposal inst
ead a SOP revision;
* Responsible for any revision requirement/commitment being implemented is refl
ected in all the SOPs and trainings affected in a timely manner;
* Responsible for the REGULUS implementation for SOP and Training revision.
Senior Incoming Quality Assurance Representative, 1997-2003
* Assure that requirements of Pharmacopoeias as well as any additional requirem
ent specifically designed for certain products are included in raw material and
packaging specifications;
* Responsible to assure the update of any item code change is revised in the BO
Ms and any other applicable system;
* Responsible for the material releases, establishment of internal controls and
measures to complete the incoming Quality Control activities in a timely matter
;
 * Responsible to inspect the vendor facilities, procedures, and suppliers proce
sses of the raw and packaging materials to be receive for manufacture to assure
Compliance;
* Responsible for the equipment compliance (maintenance and validation) at Inco
ming sampling area.
* Revise AQL to be used according to the applicable inspection program, determi
ne if the documentation needed for the process mentioned above (COAs; vendor sta
tus; deviations; Change Proposals etc.) meet the specifications and generate the
material disposition documentation and dispensing cards for raw and packaging m
aterials.
* Conduct and evaluate deviations and Change Control related to Incoming and ot
her areas;
* Assure that the MRP measures related to incoming performance are in complianc
e with production schedule.
* Responsible for the evaluation of the utilities used in manufacture (Water sy
stems; Compress Air; Environmental Monitoring);
* Responsible for technician's responsibilities by the coordination and evaluat
ion for the systems monitoring program;
* Responsible for the completion of a yearly based assessment of the utility sy
stems performance or PPQE (Periodic Performance Quality Evaluation);
* Provide recommendations and corrective actions to management to complete corr
ective and/or preventive maintenance;
* Assure that systems monitoring meet the company policies, SOPs (Standard Oper
ating Procedures) and internal specifications;
Validation/Technical Service Representative, 1994-1997
* Responsible for full preparation and execution of validation exercises design
ed to assure consistency within the parenteral manufacturing process;
* Responsible of the validation protocols; execution, and package completion of
media fills for parenteral manufacture based on the company guidelines and SOPs
requirements;
* In charge of the validation/revalidation release for purified water and water
for injection for the sterile manufacture;
* Determine if the water systems, as design, are in compliance based on the res
ults of the sampling program.
Additional Experience:
Universidad Metroolitana Del Este, Carolina, PR
Professor- 2001, General Biology Professor
EDUCATION
University of Puerto Rico Rio Piedras, PR
BS in Biology, Magna cum Laude, 1986-1991
University of Puerto Rico, Medical Science Campus Rio Piedras, PR
MS in Microbiology, Cum Laude, 1991-1994
Master in Microbiology-Molecular Biology-
Thesis investigation: Determination of Sickle Cell Haplotypes in Puerto Rican S
ubjects
Teacher assistant for the Nurse Program, Medical Science Campus, Grant by Fomen
to Econ mico de Puerto Rico
SEMINARS/
TRAININGS Upon Request
PC SKILLS Word, Excell, Power Point, Lotus Notes, Regulus, Trackwise; Master Con
trol; Pilgrim; Admin/Lims; HP; DMS; Info access; Elvis.