Quality Specialist

Job Summary Position Overview:

The incumbent will provide tactical quality support to all other functional areas. The incumbent will facilitate quality improvement and assist in nurturing the work environment toward continual improvement. The incumbent will offer quality guidance and oversight to the Company's facilities worldwide, providing assistance on quality-related issues to both internal and external customers. This position reports to the

Vice President of Global Quality Responsibilities and Duties Position Responsibilities:

Assist with the implementation and maintenance of Quality System in the Company's organization in Allentown and at theCompany's locations worldwide Ensure that customer quality requirements are consistently met Maintain and assist with quality incidents activities Maintain and assist with Corrective action/preventive action activities (CAPA) Maintain and assist with customer complaints Maintain and assist with the development/revision of quality documentation Ensure that site personnel are properly trained on quality documentation Provide quality support to Operations activities as required

Qualifications and Skills Position Requirements:

Three to five years experience in Quality Assurance/Compliance in the Pharmaceutical/Biopharmaceutical fields In-depth knowledge of FDA and DEA regulatory requirements Strong problem-solving and decision-making skills Excellent communication and interpersonal skills Strong negotiating and influencing skills Working knowledge of

Clinical Trials Job Type:

Full-time Language:

English (Required) Ability to

Commute:

Allentown, PA (Required)

Work Location:

In person