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Job Details

Quality Assurance Auditor cGMP

Company name
Bartunek Group

Salary
$50,000 - $90,000

Location
Charlotte, NC
6 hit(s)  

Profile

Salary

$50,000 - $90,000

Job Type

Direct Hire

Degree

Bachelor

Date

Apr 13, 2018

Job ID

2584224

We are looking for a Quality Assurance Auditor who has worked in a cGMP environment to be responsible for developing, maintaining and ensuring compliance.

Roles and Responsibilities:

Manage audit planning, scheduling, and execute internal audits in Facilities to assess compliance to the regulations.

Function as a backup as well as support the efforts of Supplier Quality Engineer.

Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.

Develop and implement a performance tracking system and reporting of departmental compliance.

Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary.

Assist internal departments so that they are able to understand and comply with Quality and Compliance expectations.

Assessing the Internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk.

Support training and readiness for regulatory inspections.

Provide support to Quality Assurance team.

Report audit metrics to Quality Assurance and department management.

Performance of other duties may be required for meeting compliance requirements.

Regular Attendance is required.

Communicate effectively with other departments within the organization and function within a team environment.

Perform other assigned duties as may be required in meeting company objectives

Minimum Requirements:

Knowledge of the Regulations 21 CFR 507 as well as 21 CFR 111.

Must have a minimum of 5years of experience in Quality Assurance including S

upplier Quality Management.

ASQ Certified Auditor (CQA) Certification is preferred.

Experience auditing for compliance.

Strong knowledge of GMP manufacturing regulations.

Education and Experience:

B.A or B.S in Science or Technical Field preferred

Apply

Bartunek Group

Call Us at: 913.327.8800

Email Us at: Jeri@BartunekGroup.com

Leawood, KS

Created by: Recruiters websites

Company Profile
We invite you to discover the Bartunek Difference. We are award-winning recruiting specialists in the Engineering, Manufacturing and IT industries. Whether you need direct, contract, contract to hire or project placement, let us put our 25 years of recruiting experience to work for you. You’ll quickly discern what sets us apart from other recruiters. Our individualized, consultative approach puts our clients’ interests first. We work closely with our clients to gain a complete understanding of the goal. Our keen attention to detail, unwavering focus on quality and absolute commitment to service insure you will walk away with your expectations surpassed.

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