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Technician Manufacturing

Location:
Durham NC, NC, 27713
Salary:
18.00 hr.
Posted:
July 29, 2013

Contact this candidate

Resume:

J oseph V. Daniels

**** ******** ***** ****

Durham, NC 27713

919-***-****

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

919-***-****

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

919-***-****

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

919-***-****

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

919-***-****

ab2ygi@r.postjobfree.com

REFERENCES Available Upon Request



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