J oseph V. Daniels
Durham, NC 27713
ab2ygi@r.postjobfree.com
OBJECT IVE Experienced pharmaceutical manufacturing associate seeking a full time position to
enhance production knowledge and interpersonal skills in healthcare industry.
SKILLS Proficient in Microsoft Word/Excel, Batch Record Review
WORK H ISTORY
October 2011- Present M anufacturing Associate(Small Scale/Large
Scale Pur ification)
( Cell Culture)
- Responsible for performing daily manufacturing operations in a cGMP
E nvironment
-Monitor processes against the batch record, SLR and control system.
- Document/Record and Review cGMP data and information for
p rocessing steps and/or equipment activities, following Standard
Operating Procedures. Revise documents as instructed . Key
documentation includes batch records, SLRs, and equipment log
books.
-Responsible for the application of LOTO (Lock Out Tag Out)
p rocedure before the
m aintenance of equipment is performed.
-Staging of raw components
-CIP and Pressure Testing Of Buffer Tanks And Transfer Lines
-Washing Of Di r ty Parts
-Prepping And Autoclaving I tems
-Compounding of Buffers
J oseph V. Daniels
2850 Courtney Creek Blvd
Durham, NC 27713
ab2ygi@r.postjobfree.com
-Buffer Prep for Bulk Fill Activities
-Weighing Out of Components for GMP Processes
- Sample testing of cells for Osmolality, CeDex Cell Counter, and Ph
Levels
-Bioreactor Between Batch Changeout; Installation of Probes and
F il ters, Pressure Test
and cold start
-SIP Of Bioreactors Through Automation In terface Of Delta V
Sept. 2008 – July 2011 Production Associate I I Merck Co., Durham,
NC
- Fully proficient in cGMPs and cleaning manufacturing space and equipment.
- Experienced in following prompts and commands of technical automated systems
such as MES
and Delta V.
- E xperienced in parts ordering and inventory control through SAP
- Independently made decisions regarding the cleaning schedule.
- Experienced in setup of Grade A Aseptic Environment of 250 L vessels for sterile
vaccine filling.
- Took ini tiative to give and receive feedback and take corrective action.
- Set up and operated glass washer, depyrogenation tunnel for 3 M L vials.
- Set up and operated sterile isolator filler, dosing vessel, and stopper station for
f illing.
- Set up and operated thaw and quench bath to prepare live virus vaccine for filling.
J oseph V. Daniels
2850 Courtney Creek Blvd
Durham, NC 27713
ab2ygi@r.postjobfree.com
- Performed t rouble shooting and assisted in repairs and preventative maintenance
on all
equipment.
- Performed CIP/SIP on all equipment associated as needed.
- Followed all SOP and BPRs and compiled with GMP
Oct. 2004 – Sept. 2008 Bio-Processing Technician I I Wyeth
Pharmaceuticals, Sanford, NC
Performed as filling operator in a Class 10,000 aseptic hood. Proficient in many
d ifferent areas such as Pnuemo, Purification Cold Room, Chemistry, and 110
Purification.
- Mastered documentation procedures in accordance with Good Manufacturing
P ractices.
- Demonstrated working knowledge of procedures by performing tasks and duties by
following SOPs and maintaining detailed records in a manner compliant with
cGMPs.
- Demonstrated and instructed proper gowning techniques by wearing the required
PPE to support safety in aseptic processing procedures.
- Operated and t roubleshoot production equipment such as the autoclave,
depyrogenation oven, fil ter integrity testers, etc.
- Performed sample dilutions, pH and conductivity readings.
- Cleaned and sterilized process equipment to insure prepping duties for the support
of mandatory sterile and aseptic fill processes.
- Training of new hires
Jan. 1998 – Sep. 2004 Healthcare Technician/Driver Apria Healthcare,
D urham, NC
J oseph V. Daniels
2850 Courtney Creek Blvd
Durham, NC 27713
ab2ygi@r.postjobfree.com
Demonstrated the duties of home delivery of liquid and gas oxygen, nebulizers,
oxygen concentrators, and the wri ting of Plan of Care forms on all patients to insure
t he support of monitored health statuses.
- Set up medical equipment in home environments.
- Performed inventory control.
- Maintained documentation and customer privacy to Medicare/ Private Insurance
s tandards.
- Used Universal Precautions with customer contact.
- Repaired and serviced medical equipment.
May 1996 – Jan 1998 Animal Care Technician Glaxo-Wellcome, RTP,
NC
- Demonstrated the documentation of grooming and feeding of captive animals in a
G MP
environment.
- Followed the daily cleaning schedule of several level cleanings in GMP
manufacturing
- E nsured safe environment for scientists and captive animals.
- Assisted scientists with procedures.
- Maintained contact with scientists concerning change in animal condition.
- Obtained samples.
- Used universal precautions.
EDUCAT ION
October 2008 Wake Technical Community College, Raleigh, NC
Aseptic Processing for the Incumbent Worker Certificate
May 2004 – Sep. 2004 Durham Technical Community College, Durham, NC
Biotechnology Certificate
J oseph V. Daniels
2850 Courtney Creek Blvd
Durham, NC 27713
ab2ygi@r.postjobfree.com
REFERENCES Available Upon Request