Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Warehouse

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 CAPA’s 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 (SOP’s) as required.
• Learning Management System, overseeing employee training curricula.
• · Other duties may be assigned to meet business needs.

Keys to Success:

Education

• Bachelor’s degree is required, preferably with a technical or life sciences focus. Statistics preferable.

Experience

• 3 years of experience in TSA (Transportation Security Administration) compliance preferred
• 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.

Equivalent combinations of education, training, and meaningful work experience may be considered. 

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. 

Job Tags

Remote job, Full time, Work at office, Relocation package,

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