Quality Assurance Spec 3

Sunrise Systems Inc • Columbus, NE

8 days ago

Job type

Temporary

Job description

Our client, a leading Medical Devices Manufacturing Company is looking for Quality Assurance Spec 3 and This is for an initial duration of 06 Months Contract – Columbus, NE

Job Title : Quality Assurance Spec 3

Job Id : 25-10795

Location : Columbus, NE

Duration : 06 Months Contract

Position Type : Hourly Contract Position (W2 only)

Pay rate is $31
On Site
Statistical analysis skills
Analytical skills
Technical writing skills
Communication skills
Problem solving skills
Quality system knowledge (cGMPs and ISO)

Proficient preferred :

Root cause investigation skills

Role

Units, and WW Quality Units to support resolution of customer quality issues.

Use investigation results to continually assess the adequacy of process and systems, issuing corrective actions as required to maintain an effective quality system.

Supports the quality of material and product by verifying standard operating procedures (SOP's), product specifications and Good Manufacturing Practices (GMP).

Ensures compliance with Client quality systems, policies, procedures, and best practices, and all local, state, federal and Client safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English.

Responsibilities include but are not limited to :

Investigation, prioritization, and timely response for customer complaints.

Assess the complaint vs. established quality criteria. Determine the investigation path (valid vs. information).

Effectively communicate findings thru technically written, data focused reports.

Thoroughly investigate the non-conformance, driving to a root cause and robust corrective and preventative actions.

Review batch records, change control, validation, Quality Notification trends, and other data sources as required as part of the investigation process.

Work with the other Customer Quality Specialists to ensure all complaints are being investigated and timelines for the investigation are consistently met.

Other duties as required to support the needs of the business.

Minimum Education :

Required : HSD / GED

Preferred : BA / BS – Engineering or other relevant field

Minimum Experience :

1-3 years GMP experience

Pharmaceutical / medical device experience preferred

1–3 years' experience with root cause investigation tools.

1-3 years working with within a "team environment”

Qualified candidates please send your word format updated resume at the earliest to Pavan : Pavan.p@sunrisesys.com [732-395-4444] OR Sangeeth : Sangeeth.k@sunrisesys.com [732-395-4555]

Thank You.

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Quality Assurance • Columbus, NE