QA Associate I/II

Lexington, MA
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 144507

Date Posted: 08/15/2019

QA Associate I/II


- BS degree in Biological Science or other scientific field required


- Minimum of 3-5 yrs. exp. in QA in an ISO 9001 certified QMS or equivalent


- Solid understanding of the Analytical Techniques (PH & Conductivity) required

- Basic microbiology understanding(i.e. bioburden and environmental monitoring)

- Ability to identify process deviations, assist with the writing of failure investigations and identification of corrective actions to prevent recurrence.

"Nice to Haves":

- Knowledge/exp. of advanced biochemical analysis such as HPLC is a plus.


-Will be responsible for the review of production and QC batch records, including verification of raw materials used, verification of calculations and critical process steps and evaluation of QC testing

- Review of supporting data for production activities such as environmental monitoring, reverse osmosis deionized water testing, cleaning logs and controlled temperature chamber logs.

- Will assume various administrative functions such as label generation, binding and filing production records.

- Perform batch record review

Location: Lexington, MA area

Start Date: ASAP!!

Duration: Direct Hire

Hours: Mon-Fri; 8am-5pm


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