3rd Shift, QA Specialist

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Under the general direction of the Director, Wilson Quality Operations, the Specialist is primarily responsible for supporting Third (3rd) shift Quality Assurance activities within the RotaTeq® POD facility at the Wilson, NC Site. This position will be a member of the Quality team within the RotaTeq® Integrated Process Team (IPT). The Specialist will be responsible for quality activities to support commissioning, start up, licensure, and continuing operations for the RotaTeq® POD facility at the Wilson site. The position is responsible for comprehensive oversight / management associated with the applicable Quality systems ensuring that business objectives are met within budgetary constraints and that a high standard for Quality and EHS compliance is maintained. The position will also be expected to promote behaviors of continuous improvement (aligned with MPS principles) and ensure that the Quality team maintains an inclusive culture that supports positive employee relations. Specific leadership principle expected of the Specialist include: Contributes to the performance and results of the Quality department and RotaTeq® POD IPT. Adapts, plans, and prioritizes to address operational challenges. Executes activities to ensure that all safety and compliance regulations are adhered to and enhanced, where applicable. Executes activities to meet or exceed customer expectations. Anticipates and interprets customer needs to identify solutions. Provides technical guidance to colleagues and receives guidance from manager. In addition, 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 Quality Assurance related 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 action 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 perform the final release of intermediate (for further 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 perform the final release of intermediate (for further processing) and finished goods for domestic and Canadian markets. Responsible for defect resolution and the control of material throughout the plant. Participated in the completion of significant deviations, field alerts, BPDR’s and investigational activities which span multiple sites, divisions and competencies. Able to interpret policies, regulations, etc. to determine defect classification and appropriate resolution activities and mentor others on these decisions. Completes routine stability and packaging investigations and recommends disposition of affected material. Possesses excellent technical writing skills and drives peers and customers to provide robust investigations. Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions. Monitors trends and recommends corrective actions to cease continued performance issues. Able to present data to others outside of working group to gain consensus on appropriate path forward. Provides Quality Assurance review and approval of all GMP-related SOPs. Develops programs / procedures to improve compliance status of Wilson operations. Ensures that all SOPs and documentation associated with the Quality systems are maintained and adhered to. Supports the environmental monitoring program as needed. Performs a variety of regulatory document reviews. Manages, tracks and trends a variety of compliance performance indicators, recommends appropriate actions to drive compliance improvement. Resolve and escalate issues impacting supply within 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 positive employee relations within the Qual Apply tot his job Apply To this Job