25 Feb
Quality Specialist - I (Assistant)
Vacancy expired!
Job Description
Title: Quality Specialist- I Location: West Point, PA 19486 Duration: 12+ Months Contract with possible extension Job Id: 30391 Responsibilities: The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product / process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system. He or she provides Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, and right-first-time completion of production GMP documentation. The Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. Job functions are performed primarily on the production shop floor and in a team environment. Specific responsibilities include but are not limited to the following: Assists in identifying and preparing documentation for review during a regulatory inspection. Provides coaching and mentoring of manufacturing supervisors and operators. - Performs Quality review / approval of new and updated SOPs and CJAs. Assists with training of incoming personnel and ensures compliance with departmental procedures. - Actively participates in the Tier process and uses this forum to escalate concerns and best practices. - Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Note: This is a first shift position. Quals Education Minimum Requirement: - Bachelor's degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience. Required Experience and Skills: At least three years of relevant post-degree work experience in a laboratory, manufacturing, or quality position. - Batch Record experience. Evidence of leadership skills coupled with good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Attention to detail, flexibility and an awareness of production and attendant quality control problems.Vacancy expired!