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Location

Austin, TX | United States

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Job description

Role : QA Specialist II

Location : Austin, TX - 78759

Duration : 12 Months

Shift Timings: 8 am to 6 pm Wednesday through Saturday





- 100% Onsite role.
- Open to looking at candidates from other cities in Texas who are willing to relocate to Austin at their expense.



Shift Schedule:
- Initial training for 6 to 8 weeks; Monday through Friday from 9 AM to 5PM.
- After trainirelocateng - Wednesday through Saturday from 8 AM to 6 PM5 PM.

Make sure your candidates are aware of this schedule and do not make a fuss about it later.



Skills Looking For:
The primary focus of the role will be DHR Review.
- Reviewing batch records; reviewing billed records for medical devices and sub-assemblies of medical devices.
- Work in a manufacturing environment+desk environment.
- Reviewing PDFs of computers and interacting with multiple people onsite.
- Strong attention to detail; this is a release process of medical devices so they need to be very attentive and detail-oriented.
- Able to follow procedures and review documents accurately.
- Primarily work on documentation review but may also do some work with other team members on improvement projects, document updates: tracking, and trending.
- Min 3 years of doing documentation review from a quality standpoint in the med device/pharma manufacturing environment.
- Batch records or DHRs (Device History Record).



Education and Experience:
- A bachelor's degree is mandatory (STEM background).
- Minimum 3 years of experience.
- Open to a Masters degree.
- Regardless of the level of degree, the candidate must have a minimum of 3 years of experience in reviewing quality documents in manufacturing med device/pharma background.



Top Skills:
- Strong attention to detail.
- Ability to determine whether the documents they are reviewing are acceptable per the procedures or not and if not, they need to escalate the concern.
- Previous experience in the med device/pharma manufacturing environment doing documentation reviews (batch records/DHRs).

Thanks & Regards,

Satyabachan Acharjya

Technical Recruiter

INTELLECTT INC

Ext: 351

Direct: 7327905303

Email Me: [email protected]

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Job tags

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Salary