GMP Quality Control Tech III | WF Institute for Regen Medicin

Wake Forest Baptist Health
Job Title: GMP Quality Control Tech III
Job ID: 6853
Full/Part Time: Full-Time
Regular/Temporary: Regular
Job Category: Laboratory / Animal Care
Winston-Salem, NCLaboratory / Animal Care, Medical, Healthcare6/4/2014WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE (WFIRM) Full-time Regular, 40 hours/weekJob Summary:QC Technician provides testing support of project related activities for manufacture of clinical products and/or process developmental products to ensure product safety, efficacy, and...

Job Description


WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE (WFIRM)

Full-time Regular, 40 hours/week

Job Summary:

QC Technician provides testing support of project related activities for manufacture of clinical products and/or process developmental products to ensure product safety, efficacy, and identity. Performs a variety of moderately complex and generally standardized physical, chemical and/or biological operations. Provides direction and guidance to lower level personnel.

Oral and/or written instructions received from management.

Education / Experience:

Graduation from a four-year college or university with a major in life sciences or biology, chemistry or other science related discipline and 4-6 years of related Quality Control/diagnostic laboratory testing experience.

MT(ASCP) preferred or licensure or accreditation in diagnostic testing

-

Reports To: GMP Quality Control Supervisor

Essential Functions:

Develops, implements and maintains quality control systems and activities.

Develops, implements and follows standards, methods and procedures for inspecting, testing and evaluating the identity, safety, efficacy and reproducibility of products.

Conducts routine and non-routine analysis of consumables/reagents, in-process and finished products according to SOPs.

Operates various analytical equipment and data collection software such as Flow Cytometers, Biosafety Cabinets, Microscopes, BacT/ALERT 3D Sterility, and various software to assist with recording manufacturing results and equipment.

Writes, executes and/or follows simplistic process and equipment validation documents and assists in all validation activities.

Assists and/or performs environmental monitoring activities to help maintain regulatory requirements for microbial and particulate counts in the GMP facility.

Assures that products, processes, facilities and systems conform to quality control standards and compliant with different levels of GMP.

Writes and/or revises SOPs to support internal quality control systems, data systems, technical issues and instrumentation.

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

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

Selects all requisite GMP-compliant QC Laboratory consumables and reagents.

Maintains a controlled environment in the GMP QC Laboratory setting by performing maintenance, cleaning and/or qualification of laboratory equipment.

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

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

Troubleshoots complex equipment and laboratory processes with minimum support.

Assists and supports in laboratory investigations for all product which does not confirm to specifications and notifies affected departments.

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

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.

8652 GMP Quality Control Technician III

Job Summary:
QC Technician provides testing support of project related activities for manufacture of clinical products and/or process developmental products to ensure product safety, efficacy, and identity. Performs a variety of moderately complex and generally standardized physical, chemical and/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 or other science related discipline and 4-6 years of related Quality Control experience.
-OR-
Degree from technical school and biotechnology program and 6-8 years of related Quality Control experience.
-OR-
Graduation from high school and 8+ years of related Quality Control experience.

Reports To: GMP Quality Control Supervisor/Quality Manager

Licensure, Certification and / or Registration:

Essential Functions:

1.Develops, implements and maintains quality control systems and activities.
2.Develops, implements and follows standards, methods and procedures for inspecting, testing and evaluating the identity, safety, efficacy and reproducibility of products.
3.Conducts routine and non-routine analysis of consumables/reagents, in-process and finished products according to SOPs.
4.Operates various analytical equipment and data collection software such as Flow Cytometers, Biosafety Cabinets, Microscopes, BacT/ALERT 3D Sterility, NextDocs and Blue Mountain Regulatory Asset Manager.
5.Writes, executes and/or follows simplistic process and equipment validation documents and assists in all validation activities.
6.Assists and/or performs environmental monitoring activities to help maintain regulatory requirements for microbial and particulate counts in the GMP facility.
7.Assures that products, processes, facilities and systems conform to quality control standards and GMP regulations.
8.Writes and/or revises SOPs to support internal quality control systems, data systems, technical issues and instrumentation.
9.Reviews relevant FDA Code of Federal Regulation sections to demonstrate full GMP understanding.
11.Passes stringent GMP gowning and aseptic processing qualifications to attain/verify skill level consistent with working in a GMP environment.
12.Selects all requisite GMP QC Laboratory consumables and reagents.
13.Maintains a controlled environment in the GMP QC Laboratory setting by performing maintenance, cleaning and/or qualification of laboratory equipment.
14.Trains lower level personnel on complex equipment functions and laboratory processes.
15.Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.
16.Troubleshoots complex equipment and laboratory processes with minimum support.
17.Assists and supports in laboratory investigations for all product which does not confirm to specifications and notifies affected departments.
18.Ensures GMP regulatory compliance via partnership with Quality Assurance, Facilities Engineering and Manufacturing personnel.
19.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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