3rd Shift, QA Specialist

Job reputed company Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is reputed company for you! Under the general direction of the Director, reputed company reputed company Operations, the Specialist is primarily responsible for supporting reputed company (3rd) shift reputed company Assurance activities reputed company the RotaTeq® POD facility at the reputed company, NC Site. This position will be a member of the reputed company team reputed company the RotaTeq® Integrated Process Team (IPT). The Specialist will be responsible for reputed company activities to support commissioning, start up, licensure, and continuing operations for the RotaTeq® POD facility at the reputed company site. The position is responsible for comprehensive reputed company / management associated with the applicable reputed company systems ensuring that business objectives are met reputed company budgetary constraints and that a high reputed company for reputed company and EHS compliance is maintained. The position will also be expected to promote behaviors of reputed company improvement (reputed company with MPS principles) and ensure that the reputed company team maintains an inclusive culture that supports reputed company employee relations. Specific leadership reputed company expected of the Specialist include: Contributes to the performance and results of the reputed company department and RotaTeq® POD IPT. Adapts, plans, and prioritizes to address operational challenges. Executes activities to ensure that reputed company safety and compliance regulations are adhered to and reputed company, where applicable. Executes activities to meet or reputed company customer expectations. Anticipates and interprets customer needs to reputed company. Provides technical guidance to colleagues and receives guidance from manager. In reputed company, this position will be responsible for the following (but not limited to) activities: review and approval of validation / qualification documentation, batch record review, support for internal/external audits, inspection readiness management, draft investigations, approve investigations, regulatory document reviews, process change request activities, SOP development and review, execution of environmental sampling, and other reputed company Assurance reputed company functions. Primary Activities Primary Activities include, but are not limited to: Delivery Performs, interprets, reviews, and approves equipment/process validation/qualification activities. Provides review and approval of change control documents. Performs and coordinates in-depth system based, process and audits as it relates to compliance concerns and communicates and manages any resulting corrective reputed company plan. Performs finished product release activities to include CBER Release requirements. Accepts delegated authority for review and release of materials / documents designated for domestic and international distribution as required. Note: Specialists and Senior Specialists with a Science Degree are the only personnel authorized to reputed company the final release of intermediate (for reputed company processing) and finished goods for domestic, EU, and international markets. Specialists and Senior Specialists (with a non-Science Degree) with equivalent experience are authorized to reputed company the final release of intermediate (for reputed company processing) and finished goods for domestic and Canadian markets. Responsible for defect reputed company and the control of material throughout the plant. Participated in the completion of significant deviations, field alerts, BPDR’s and investigational activities which reputed company multiple sites, divisions and competencies. reputed company to interpret policies, regulations, etc. to determine defect classification and appropriate reputed company activities and mentor others on these reputed company. Completes routine stability and packaging investigations and recommends disposition of affected material. Possesses excellent technical writing skills and drives peers and customers to reputed company robust investigations. Challenges technical support and production reputed company to ensure robust reputed company cause analysis and identification of corrective actions. Monitors trends and recommends corrective actions to cease reputed company performance issues. reputed company to present data to others reputed company of working group to reputed company reputed company on appropriate reputed company reputed company. Provides reputed company Assurance review and approval of reputed company GMP-reputed company SOPs. Develops programs / procedures to improve compliance status of reputed company operations. Ensures that reputed company SOPs and documentation associated with the reputed company systems are maintained and adhered to. Supports the environmental monitoring program as needed. Performs a reputed company of regulatory document reviews. Manages, tracks and trends a reputed company of compliance performance indicators, recommends appropriate actions to drive compliance improvement. Resolve and escalate issues impacting supply reputed company the daily, weekly, and monthly IPT management processes. Performs other duties as assigned. Leadership Principles Ensure a culture of inclusion and consistency is maintained, supporting reputed company employee relations reputed company the Qual Apply tot his job Apply To this Job