Quality Control Associate

The Operations Test Associate candidate will be responsible for performing

QC release testing and analysis

of raw materials, in-process, and finished goods for the

Molecular Diagnostics Division . The candidate will be responsible for understanding and executing testing on multiple assay platforms in a

cGMP environment

to ensure timely release of products. Qualifications

Bachelors degree in a science related field

1 to 2 years of

industrial lab experience

(preferably QC)

Working knowledge of

industry/regulatory standards

and

GMP/GLP requirements

Preferred working knowledge of

Enterprise Resource Planning

( ERP ),

LIMS , and/or

QSR

Responsibilities

Performs routine testing using

GMP/GLP practices

Performs

data analysis and results interpretations

comparing to protocol-defined specifications, validity criteria, and alert limits

May perform

microbiology testing

and activities for the QC Micro team

May perform

pH and/or HPLC testing

for the QC Analytical team

Responsible for maintaining

product and QC material inventories

Responsible for the

maintenance and cleanliness of the laboratory , stocking shelves/drawers with testing materials

Responsible for the

maintenance and cleanliness of equipment , calibrating or submitting items for calibration as needed

Responsible for completing

training in a timely manner

and maintaining the records

Participates in

Laboratory Investigations

for Invalid assays and Out-of-Specifications results

Prepares documents for storage in our

document management system

and manages original data files

Seniority level

Associate

Employment type

Contract

Job function

Other

Industries

Medical Equipment Manufacturing

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