Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Warehouse
Job Description
Location/Division Specific Information
The Thermo Fisher Scientific Swedesboro site is part of the PSG-CTD Division. It is a multi-product and multi-client biopharmaceutical site supporting Clinical Ancillary Management (CAM). We provide storage and order fulfillment of commercial and commercial-free pharmaceutical products for our clients. We have capabilities to support and store products that require cold chain and ambient processing.
Discover Impactful Work:
The QA Engineer II will play a crucial role in maintaining Quality oversight within all operations of the business while continuously looking for ways to develop and improve systems.
A day in the Life:
- Tracks open records in TrackWise to include Deviations Complaints CAPAs observations and Change Controls to closure.
- Supports during client and regulatory audits and inspections as well as with responses to findings and CAPAs as applicable.
- TSA Principle Security Officer to include collaborating with TSA personnel requesting shipping documents and TSA agent walkthroughs of the facility.
- Document creation & control within electronic document system to include making recommendations to draft documents revising QA documents and Standard Operating Procedures (SOPs) as required.
- Learning Management System overseeing employee training curricula.
- Other duties may be assigned to meet business needs.
Keys to Success:
Education
- Bachelors degree is required preferably with a technical or life sciences focus. Statistics preferable.
Experience
- Minimum of 3 years of experience in TSA (Transportation Security Administration) compliance.
- Extensive knowledge and application of GMP (Good Manufacturing Practices) within pharmaceutical quality systems.
Knowledge Skills Abilities
- Mastery of skills required to read understand and adhere to the SOPs and policies of a GMP environment.
- Must have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks.
Physical Requirements / Work Environment
- This position is administrative and is positioned in an office environment.
- It requires standing bending reaching walking and talking as well as exerting up to 20lbs.
Relocation assistance is NOT provided
Must be legally authorized to work in the United States without sponsorship now or in the future.
Must be able to pass a comprehensive background check which includes a drug screening.
Required Experience:
IC
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Office WarehouseJob DescriptionLocation/Division Specific InformationThe Thermo Fisher Scientific Swedesboro site is part of the PSG-CTD Division. It is a multi-product and mul...
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Warehouse
Job Description
Location/Division Specific Information
The Thermo Fisher Scientific Swedesboro site is part of the PSG-CTD Division. It is a multi-product and multi-client biopharmaceutical site supporting Clinical Ancillary Management (CAM). We provide storage and order fulfillment of commercial and commercial-free pharmaceutical products for our clients. We have capabilities to support and store products that require cold chain and ambient processing.
Discover Impactful Work:
The QA Engineer II will play a crucial role in maintaining Quality oversight within all operations of the business while continuously looking for ways to develop and improve systems.
A day in the Life:
- Tracks open records in TrackWise to include Deviations Complaints CAPAs observations and Change Controls to closure.
- Supports during client and regulatory audits and inspections as well as with responses to findings and CAPAs as applicable.
- TSA Principle Security Officer to include collaborating with TSA personnel requesting shipping documents and TSA agent walkthroughs of the facility.
- Document creation & control within electronic document system to include making recommendations to draft documents revising QA documents and Standard Operating Procedures (SOPs) as required.
- Learning Management System overseeing employee training curricula.
- Other duties may be assigned to meet business needs.
Keys to Success:
Education
- Bachelors degree is required preferably with a technical or life sciences focus. Statistics preferable.
Experience
- Minimum of 3 years of experience in TSA (Transportation Security Administration) compliance.
- Extensive knowledge and application of GMP (Good Manufacturing Practices) within pharmaceutical quality systems.
Knowledge Skills Abilities
- Mastery of skills required to read understand and adhere to the SOPs and policies of a GMP environment.
- Must have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks.
Physical Requirements / Work Environment
- This position is administrative and is positioned in an office environment.
- It requires standing bending reaching walking and talking as well as exerting up to 20lbs.
Relocation assistance is NOT provided
Must be legally authorized to work in the United States without sponsorship now or in the future.
Must be able to pass a comprehensive background check which includes a drug screening.
Required Experience:
IC
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