QA Technician - 2nd shift

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Monitor and maintain compliance with regulatory requirements (cGMP and EU) and internal SOPs. Perform various sampling activities including maintaining control of samples and associated material documentation. Perform audits of documentation supporting those activities referenced above. Represent a positive and compliant presence throughout the organization. Represent a positive and compliant presence throughout the organization.? Monitor and maintain SOP and cGMP compliance regarding production, warehouse activities, and safety issues and provide observations reports.? Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.? Maintain all QA-related paperwork and filing.? Perform cleaning verification for room and equipment release for batches of intermediate material.? Documentation audits include but are not limited to the following:? Batch Records? Room, Equipment, and Utility Logbooks? Production cleaning records? Protocols ? Training records? General and Serialized Forms? Room and Equipment Clearance checklist? Audit materials to ensure appropriate use and SAP record accuracy.? Assist with product and material inspections as necessary.? Collect manufacturing data for metrics? Assist in the overseeing and auditing of controlled substances.? Assist with investigations and implementation of CAPA related to SOP/cGMP issues.? Be proficient in databases (i.e. SAP, LIMS, cME).? Verify appropriate material usage and status.? Sample raw materials and submit samples to Quality Control. ? Maintain sampling area and supplies.? Prepare and submit authorizations for material reclassification/raw material disposition.Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? Bachelor?s Degree required. Scientific discipline is preferred. Applicable experience may be substituted in lieu of degree.? 0+ years of quality assurance or quality control experience in a pharmaceutical or regulated environment? Familiarity with cGMP regulations? Excellent communication and technical writing skills ? Ability to work in a team-oriented environment, as well as work independently? Computer literate in Microsoft Office software and basic database knowledge? Ability to lift 50-lb. containers (23 kg) Apply to Shire