GMP Manufacturing Tech III | WF Institute for Regen Medicin

Wake Forest Baptist Health
Job Title: GMP Manufacturing Tech III
Job ID: 6448
Full/Part Time: Full-Time
Regular/Temporary: Regular
Job Category: Laboratory / Animal Care
Winston-Salem, NCLaboratory / Animal Care, Medical, Healthcare4/4/2014WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE Full-time Regular, 40 hours/weekJob Summary:Manufacturing Technician conducts project related activities for manufacture of process developmental and clinical materials. Performs a variety of moderately complex and generally standardized...

Job Description


WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE

Full-time Regular, 40 hours/week

Job Summary:

Manufacturing Technician conducts project related activities for manufacture of process developmental and clinical materials. Performs a variety of moderately complex and generally standardized physical, chemical, or biological operations using validated equipment and procedures. Provides direction and guidance to lower level personnel.

Oral and/or written instructions received from supervisor.

Education / Experience:

Graduation from a four-year college or university with a major in life sciences or biology, chemistry, zoology, or other science related discipline and 2-4 years of related experience.

Reports To: GMP Manufacturing Supervisor/Director of Manufacturing

Essential Functions:

Executes manufacturing for multiple Phase I and Phase II clinical trials in the GMP facility.

Executes and follows developmental processes related to project defined work.

Develops, implements and follows standardized production processes including cell/tissue isolation and cell/expansionprocessing, cell cryopreservation and biomaterials manufacture.

Writes, revises and executes batch records and follows SOPs in support of projects/processes that move into the GMP facility.

Reviews relevant FDA Code of Federal Regulation sections to demonstrate full GMP understanding.

Passes stringent GMP gowning and aseptic processing qualifications to attain/verify skill level consistent with working in a GMP environment.

Selects all requisite GMP manufacturing consumables and reagents.

Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.

Operates a variety of validated equipment including but not limited to centrifuges, microscopes, biosafety cabinets, incubators and liquid nitrogen freezers.

Trains lower level personnel on complex equipment functions and manufacturing processes.


Maintains cleanroom environment in GMP setting by performing scheduled cleaning of all equipment and/or manufacturing areas.

Ensures GMP regulatory compliance via partnership with Quality Assurance, Quality Control and Facilities Engineering personnel.

Troubleshoots complex equipment and manufacturing processes with minimum support.

Supports Facilities,Quality, IT, and Procurement activities required for daily GMP operation for equipment and processes.

Assures that products, processes, facilities and systems conform to quality standards and GMP regulations.

Takes initiative to identify opportunities for process improvement and implementation.

Skills and Qualifications:

Excellent recordkeeping and documentation skills.

Strong communication skills, both verbal and written.

Understanding of Microsoft Excel, Word and other computer software.

Outstanding interpersonal skills, high energy and motivated.

Good Manufacturing Practices (GMP) experience required.

8648 GMP Manufacturing Technician III

Job Summary:
Manufacturing Technician conducts project related activities for manufacture of process developmental and clinical materials. Performs a variety of moderately complex and generally standardized physical, chemical, or biological operations using validated equipment and procedures. Provides direction and guidance to lower level personnel.

Oral and/or written instructions received from supervisor.

Education / Experience:
Graduation from a four-year college or university with a major in life sciences or biology, chemistry, zoology, or other science related discipline and 2-4 years of related experience.
-OR-
Associate?s degree, degree from technical school or biotechnology program and 4-6 years of related experience.
-OR-
Graduation from high school and 6+ years of related experience.

Reports To: GMP Manufacturing Supervisor/Director of Manufacturing

Licensure, Certification and / or Registration:

Essential Functions:

1.Executes manufacturing for multiple Phase I and Phase II clinical trials in the GMP facility.
2.Executes and follows developmental processes related to project defined work.
3.Develops, implements and follows standardized production processes including cell isolation and expansion, and biomaterials manufacture.
4.Writes, revises and executes batch records and follows SOPs in support of projects/processes that move into the GMP facility.
5.Reviews relevant FDA Code of Federal Regulation sections to demonstrate full GMP understanding.
6.Passes stringent GMP gowning and aseptic processing qualifications to attain/verify skill level consistent with working in a GMP environment.
7.Selects all requisite GMP manufacturing consumables and reagents.
8.Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.
9.Operates a variety of validated equipment including but not limited to centrifuges, microscopes, biosafety cabinets, incubators and liquid nitrogen freezers.
10.Trains lower level personnel on complex equipment functions and manufacturing processes.
11.Maintains cleanroom environment in GMP setting by performing scheduled cleaning of all equipment and/or manufacturing areas.
12.Ensures GMP regulatory compliance via partnership with Quality Assurance, Quality Control and Facilities Engineering personnel.
13.Troubleshoots complex equipment and manufacturing processes with minimum support.
14.Supports Facilities, Quality, IT, and Procurement activities required for daily GMP operation for equipment and processes.
15.Assures that products, processes, facilities and systems conform to quality standards and GMP regulations.
16.Takes initiative to identify opportunities for process improvement and implementation.

Skills and Qualifications:
Excellent recordkeeping and documentation skills.
Strong communication skills, both verbal and written.
Understanding of Microsoft Excel, Word and other computer software.
Outstanding interpersonal skills, high energy and motivated.
Good Manufacturing Practices (GMP) experience required.

?
Physical Requirements:
Amount of time spent performing the following activities:
0% 35% 65%
to to to
35% 65% 100% N/A Activity
x Standing
x Walking
x Sitting
x Bending
x Reaching with arms
x Finger and hand dexterity
x Talking
x Hearing
x Seeing
x Lifting, carrying, pushing and or pulling:
x 20 lbs. maximum
x 50 lbs. maximum
x 100 lbs. maximum

Work Environment:
The Regenerative Medicine Clinical Center (RMCC) is constructed to enable the production of tissue engineered products for evaluation in Phase I/II clinical studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations for biological products and human cells, tissues, and cell and tissue based products.

The RMCC consists of ISO 7 and ISO 8 classified cleanroom space along with an external Quality Control Laboratory and Warehouse. Access to all classified areas requires appropriate gowning and aseptic techniques.

To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".

Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-0175. Office hours are Monday-Friday, 8:00am-5:00pm.

If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at accommodationrequest@wakehealth.edu.

It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.



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