KVK Tech, Inc.
Overview
QMS Associate role at KVK Tech, Inc. in Newtown, PA. The QA Associate ensures quality and compliance of the facility with applicable regulatory requirements. This includes reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analyses and reporting metrics, and providing quality/compliance training as needed. Support during regulatory inspections and assist with development of SOPs, specifications, and other quality document control activities as needed. Responsibilities
Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices, including sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation), and safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. Perform regularly scheduled internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations. Review SOPs, Specifications, Batch Record Documentation. Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and guidelines, and present to the Quality Council. Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recalls, OOS and Outliers) to ensure compliance with procedures and due dates. Qualifications
Ability to read, identify, transcribe, and communicate details accurately. Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision. Must be able to multi-task and work in a fast-paced environment. Self-motivated with exceptional organizational skills. Ability and willingness to work cooperatively with others. Knowledge of Microsoft Office products (Word, Excel). Benefits
401(k) with matching Health, Vision, Dental Insurance Childcare Scholarship Tuition Reimbursement Bonus Pay + Merit Increases Paid Time Off Flexible Holidays We Are Looking For Applicants With Ability to read, identify, transcribe, and communicate details accurately. Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision. Must be able to multi-task and work in a fast-paced environment. Self-motivated & exceptional organizational skills. Ability and willingness to work cooperatively with others. Knowledge of Microsoft Office products (Word, Excel). KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you. Apply for this position
#J-18808-Ljbffr
QMS Associate role at KVK Tech, Inc. in Newtown, PA. The QA Associate ensures quality and compliance of the facility with applicable regulatory requirements. This includes reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analyses and reporting metrics, and providing quality/compliance training as needed. Support during regulatory inspections and assist with development of SOPs, specifications, and other quality document control activities as needed. Responsibilities
Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices, including sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation), and safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. Perform regularly scheduled internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations. Review SOPs, Specifications, Batch Record Documentation. Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and guidelines, and present to the Quality Council. Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recalls, OOS and Outliers) to ensure compliance with procedures and due dates. Qualifications
Ability to read, identify, transcribe, and communicate details accurately. Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision. Must be able to multi-task and work in a fast-paced environment. Self-motivated with exceptional organizational skills. Ability and willingness to work cooperatively with others. Knowledge of Microsoft Office products (Word, Excel). Benefits
401(k) with matching Health, Vision, Dental Insurance Childcare Scholarship Tuition Reimbursement Bonus Pay + Merit Increases Paid Time Off Flexible Holidays We Are Looking For Applicants With Ability to read, identify, transcribe, and communicate details accurately. Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision. Must be able to multi-task and work in a fast-paced environment. Self-motivated & exceptional organizational skills. Ability and willingness to work cooperatively with others. Knowledge of Microsoft Office products (Word, Excel). KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you. Apply for this position
#J-18808-Ljbffr