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Job Details

Quality Assurance Auditor cGMP

Company name
Apple & Associates, Inc.

65,000 - $90,000

Lancaster, SC
2 hit(s)  


Job ID


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

Company Profile
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.

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