Highlights
Basic Requirements: AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience Physical Environment and Physical Requirements: Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees). The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.
Numbers & Facts
| Location | Frederick, MD |
| Industry | Computer/IT Services |
| Salary | $28.71 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: cGMP Cleaner
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: cGMP Cleaner
Location: Frederick, MD
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Type: Temporary Assignment
Work Type: Onsite
Shift Timing: Monday to Friday From 7:30am to 4:00pm
Job Description:
- GMP cleaning team.
- Client is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies.
- We have two commercial products, Yescarta and Tecartus , along with a robust pipeline of various autologous and allogeneic clinical programs.
- We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Client's brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
- The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.
Responsibilities
- Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
- Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
- Maintains accurate and complete records
- Attends and completes all training required by Company SOPs, procedures and policies
- Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
- Reviews and provides signatory signoff of documentation
- Provides accurate and complete assistance to other Departments as needed
- Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
- Perform any other tasks/duties as assigned by management
- Embrace the QUALITY culture
Basic Requirements:
- AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience Physical Environment and Physical Requirements:
- Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
- Ability to wear a respirator during use of certain cleaning chemicals
- Perform operations within an ISO Class clean rooms
- Employee must be able to occasionally lift and/or move up to 40 pounds
- Must be able to squat, bend, kneel, and or reach for 80% of a shift
Must be able to stand, walk, and/or move about for 80% of a shift Preferred Qualifications:
- Clean Room sanitization experience or cGMP operational experience a plus Task break down (by %): 75% cleaning 15% documentation 10% other duties as assigned
TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.