Quality Assurance Manager

SCHOTT AG•Lebanon, PA

33d

About The Position

Your Contribution Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectives Assist in developing department budget and investment plan(s) according to strategic goals Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews Support the development and updating of Quality Assurance programs, policies, processes, procedures and controls Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies Manage the review of batch records and avoid impacting shipment dates Manage Department Training Coordinator activities and projects Manage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documents Lead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirements Measure and analyze Quality System trends Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS) Maintain the Archive Room and document retention requirements Write and revise Standard Operating Procedures (SOPs) and provide training, as required Manage the CAPA and Change-Control process to include, issuing, reviewing and approving steps Support all customer or registrar quality related audits and/or evaluations Utilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business Unit Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findings Help promote and implement safety/EHS directives and maintain a clean and safe workspace Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines Your Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, required Minimum three years of experience in Quality leadership role Solid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISO Exposure to the glass forming industry and/or pharmaceutical industry, preferred Thorough MS Office applications, SAP and electronic QMS systems Multi-tasking abilities Decision making Detail oriented approach Forward/creative thinking Service oriented Effective communication skills Ability to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and vision Short and long term disability Tuition reimbursement Paid time off Pet insurance Other supplemental benefits available upon election Please feel free to contact us

Requirements

Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, required
Minimum three years of experience in Quality leadership role
Solid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISO
Thorough MS Office applications, SAP and electronic QMS systems
Multi-tasking abilities
Decision making
Detail oriented approach
Forward/creative thinking
Service oriented
Effective communication skills
Ability to read, write and speak English language

Nice To Haves

Exposure to the glass forming industry and/or pharmaceutical industry, preferred

Responsibilities

Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectives
Assist in developing department budget and investment plan(s) according to strategic goals
Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews
Support the development and updating of Quality Assurance programs, policies, processes, procedures and controls
Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies
Manage the review of batch records and avoid impacting shipment dates
Manage Department Training Coordinator activities and projects
Manage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documents
Lead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirements
Measure and analyze Quality System trends
Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)
Maintain the Archive Room and document retention requirements
Write and revise Standard Operating Procedures (SOPs) and provide training, as required
Manage the CAPA and Change-Control process to include, issuing, reviewing and approving steps
Support all customer or registrar quality related audits and/or evaluations
Utilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business Unit
Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findings
Help promote and implement safety/EHS directives and maintain a clean and safe workspace
Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines