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Quality Systems Specialist
29 Jul 2022
: Quality Systems Specialist
SCHOTT Pharmaceutical Packaging (Lebanon, PA) is a division of SCHOTT North America and is one of the most respected suppliers of high quality glass tubing containers for parenteral products in North America. SCHOTT PPP offers technological leadership and innovation as well as outstanding customer care for both local and multi-national clients, whether it is packaging for liquid, lyophilized or powder products.
Education - BS Degree in Engineering, Science or related field
Experience managing Quality Systems and/or Quality Documentation (cGMP preferred)
Demonstrated knowledge of ISO9001, ISO15378 or ISO13485
Experience and knowledge related to regulatory requirements for pharmaceutical and/or medical device industries (heavily preferred)
Experience and knowledge using SAP and C-Pro
Experience and knowledge using MS Office
Demonstrated communication skills (written / oral) including the ability to read/speak English
Ability and willingness to work in office and in a production floor setting with moderate noise
Ability and willingness to work in fast-paced, matrix structured organization
Ability and willingness to work traditional Mon-Fri work week (8am - 5pm) w/ flexibility
SUMMARY / RESPONSIBILITIES:
This Quality Systems Specialist will provide oversight of SCHOTT's quality systems and possess knowledge of Quality Systems and regulatory requirements and has knowledge of GMPs, Quality Systems, Deviation, CAPA, Change Control. Works on multiple assignments in collaboration with various department system owners. In addition, help define and implement short and long-term strategies to achieve departmental goals and site objectives, while reporting on Key Performance Indicators (KPI) regularly. Potential
duties/responsibilities include (but are not limited to)
Ensure Quality Systems conform to regulations and quality policies.
Assist Department Managers in understanding global requirements with regard to Quality Systems.
Serve as site Subject Matter Expert (SME) for defined Quality Systems.
Manage the Change Control process and metrics reporting
Manage the CAPA and SCAR proceses, to include: issuing, reviewing, approving and performing effectiveness checks and metric reporting
Manage the NC process and metric reporting
Develop, Coordinate, and lead Quality Systems governance & oversite meetings.
Engage with key stakeholders and site leaders to ensure timely closure of Quality Actions.
Support, develop and deliver technical and/or compliance training
Identify and advance compliance gaps across quality systems.
Generate and revise standard operating procedures and associated documents as needed.
Identify compliance risks and raise the issues to appropriate levels of management for resolution.
Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner as a result of customer complaints or customer audit findings
Ensure execution of global CAPAs, while confirming effectiveness
Complete trend analysis for Quality data (i.e. Nonconformances, CAPA, etc)
Assist in customer audits and inspections conducted by regulatory organizations, as needed
Follow cGMP and adhere to all ISO and safety guidelines and policies
Perform other duties as assigned.
Apply for this job now
29 July 2022
Science & Technology