Easter Seals Jobs

Description

Purpose and Scope Manage the development and implementation of policies, processes, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Provide management oversight and leadership to the Quality Control Chemistry staff, which includes investigators, instrumentation lifecycle specialists, sampling personnel, and the laboratory administrator. Essential Duties & Responsibilities Organize, oversees and evaluates daily QC Chemistry laboratory operations to maintain Quality Standards and project timelines, including prioritization and execution of work, coordination with internal and external stakeholders, and communication with leadership. Communicate priorities related to investigations, change controls, releases, ordering, instrumentation, and CAPAs generated in the QCC laboratories according to established timelines. Oversee the generation, documentation and compliance of deviations, investigations, CAPA change controls, ordering and instrumentation. Oversee the incoming sampling program. Conduct, authors or approves deviations related to QCC Analytical procedures to investigate root cause, determine impact and corrective and preventative actions. Perform data trending related to deviations and OOS to drive down recurrence. Reviews proposed changes to quality systems, procedures, methods, to determine impact to the laboratory. Collaborate with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed in accordance with Tolmar procedures. Author, revise and approve controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, submissions to regulatory agencies and work instructions. Author, review, and approve change controls related to method changes, specification revisions, and instrumentation. Perform impact and change assessments for laboratory related change controls, including responses to audit findings in EQMS. Review and approve purchase requests and invoices and ensure monthly budget adherence. Ensure back-ordered items are escalated and addressed in a timely manner. Ensure compliance with sample submission form review and verification. Ensure compliance with periodic review processes. Adheres to the department budget while managing exigencies, established company goals, and new market opportunities. Identify large-scale cost-saving measures to reduce overall costs. Provide guidance to project teams on the implementation of new laboratory systems. Lead the department with evaluation and implementation of new systems, and training for continuous improvement efforts. Collaborate cross-site and cross-departmentally to maintain effective and efficient processes, appropriate deployment of resources and ensure procedures are established and followed. Perform trending, reporting and communication of laboratory data including department KPIs , individual team performance metrics and progress towards department and company goals. Monitor and revise GxP systems currently in place to ensure compliance with established SOPs, policies, cGMPs and other relevant regulatory requirements. Enable and drive technical and transferable skill development and empowerment of employees while holding them accountable for activities required to meet deadlines. Manage, monitor, revise and approve new CBT content of the QCC training program. Participate in the hiring, mentoring, developing and retention of junior talent. Participate and lead by example to recognize and reward top performing talent utilizing established reward and recognition programs and systems. Participates in and supports development and implementation of Operational Excellence initiatives including tracking ROI of associated projects which enhance laboratory and staff efficiency. Assist departmental director in providing QCC versight of compliance processes, including document review and approvals. Remains up to date with advancements in laboratory operations and lean excellence. Participate in daily and weekly project team meetings. Participate in third party and regulatory audits. Serves as a lead for internal audits of QCC. Generate Certificate of Analysis (CoA) and reviews stability reports as required. Maintains a safe working environment in the laboratory including reporting and trending of SOSPES observations. Maintains an atmosphere of teamwork, cordiality and respect towards coworkers. Participates in the required annual hazardous waste training. Respond to spills per the Chemical Spill Procedures. Performs other duties as business demands. Knowledge, Skills & Abilities Excellent leadership and supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs. Expert knowledge of regulations related to deviations, investigations, CAPA, change control and instrumentation. Proficient knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage. Extensive knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP. Adept at applying cGMP in a for conformance to US, EU and ROW standards. Expert in conducting investigations, writing deviations, implementing CAPA and initiating change controls. Experience working with suppliers to resolve issues related to sampling. Experience in monitoring and revising KPIs to consistently improve laboratory performance. Experience leading audits and inspections.