Hi,

We have an excellent opportunity for “QA Specialist” with Direct client. If this sounds interesting please send the following details or do call me on (609)-454-3209 Ext 116.

Position Details:

Job Title: QA Specialist

Job Location:Devens, MA

Duration: 6+ Months

Job Description

The Supplier Quality Specialist will focus on Quality review and approval of supplier documents to support qualification of GMP starting materials for biologics (large molecules) drug substances. The scope of documents will range from TSE/BSE statements through Quality release of supplier products. Specific technical document types include stability/ lifecycle of materials, test method comparisons and risk assessments. This Quality role will also partner with Procurement teams to source, resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.

Major Duties and Responsibilities:

Assist with the lifecycle management of material qualifications, including reduced testing and direct dispense.

Assist with quality review of risk assessments associated with material qualification.

Performs quality assessment of Supplier Change Notifications for impact to site.

Assists in discrepancy reporting, deviations and CAPAs associated with nonconforming/defect material.

Performs quality review for area documents including SOPs, Technical Documents/Reports and Forms.

Assist in resolution of supplier/material related issues as they arise.

Assist team on cross-site improvement initiates.

Requirements:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.

• A minimum of 4 years with directly relevant experience in a regulated environment is required.

• Knowledge of regulated activities such as Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).

• Demonstrate proficiency in common computer tools such as word processing, spreadsheet and web based applications.

• Past experience where one was required to work in a team based environment with a diverse group of people.

• Previous work experience where attention to detail and personal accountability were critical to success.

• Strong communication skills and the ability to follow written and verbal instructions.

Job Type: Contract

Pay: $33.00 - $38.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Work Location: In person

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