Merck
Associate Specialist, Quality Systems & Compliance
Merck, Omaha, Nebraska, United States, 68102
Associate Specialist, Quality Assurance
The Associate Specialist, Quality Assurance is accountable for review and approval of documentation to support current Good Manufacturing Practice (cGMP) to ensure compliance with 9CFR, 21CFR, and our company's Animal Health Quality Manual requirements. Independently performs routine audits of data, investigations, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), Data Integrity, and other applicable regulations and our Company procedures. Collaborates with the Site Quality Head (SQH) with Quality Systems including site Change Controls, Deviation Investigations and Corrective Actions, Preventative Actions, etc., as applicable. Works with Omaha Distribution Center (ODC) personnel to ensure resolution of audit findings and notifies relevant management of unresolved issues/trends. Assist in self-inspection audits for the Omaha Distribution Center. Perform audits of contract sites as needed. The Associate Specialist will become knowledgeable in regulatory requirements, cGMPs, GDPs, and our local procedures to assure site compliance. Primary responsibilities include but are not limited to the following: Basic knowledge of USDA, FDA, DEA, and EPA regulations. Perform GMP review of deviations and change management records, etc. Perform GMP documentation review and approval for Finished Product Packaged (FPP), deviation and/or out-of-specification approval, change management approval, etc. Support the Site Quality Head on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables. Accountable for all assigned projects and communication of status to the Management team. Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system development and approval. Identify and implement continuous improvement initiatives and action plans. Assist in preparations for regulatory agency inspections. Good communication and technical writing skills. Additional duties and/or projects as assigned. Education Minimum Requirements: B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology). Required Experience and Skills: Two (2)+ years of experience in Quality System Management. Strong CAPA and investigation experience. Reliance review experience. Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, interpersonal and conflict resolution skills. Ability to manage multiple priorities and projects simultaneously. Attention to detail, flexibility, and an awareness of quality problems. Preferred Experience and Skills: Experience in Pharmaceutical/Biological or related industry in quality control, quality assurance, manufacturing, or distribution. Knowledge of 9CFR and 21CFR requirements for product distribution and quality systems. Knowledge of Cold Chain Management within the global supply chain. Knowledge of SAP. Eight step problem-solving. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
The Associate Specialist, Quality Assurance is accountable for review and approval of documentation to support current Good Manufacturing Practice (cGMP) to ensure compliance with 9CFR, 21CFR, and our company's Animal Health Quality Manual requirements. Independently performs routine audits of data, investigations, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), Data Integrity, and other applicable regulations and our Company procedures. Collaborates with the Site Quality Head (SQH) with Quality Systems including site Change Controls, Deviation Investigations and Corrective Actions, Preventative Actions, etc., as applicable. Works with Omaha Distribution Center (ODC) personnel to ensure resolution of audit findings and notifies relevant management of unresolved issues/trends. Assist in self-inspection audits for the Omaha Distribution Center. Perform audits of contract sites as needed. The Associate Specialist will become knowledgeable in regulatory requirements, cGMPs, GDPs, and our local procedures to assure site compliance. Primary responsibilities include but are not limited to the following: Basic knowledge of USDA, FDA, DEA, and EPA regulations. Perform GMP review of deviations and change management records, etc. Perform GMP documentation review and approval for Finished Product Packaged (FPP), deviation and/or out-of-specification approval, change management approval, etc. Support the Site Quality Head on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables. Accountable for all assigned projects and communication of status to the Management team. Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system development and approval. Identify and implement continuous improvement initiatives and action plans. Assist in preparations for regulatory agency inspections. Good communication and technical writing skills. Additional duties and/or projects as assigned. Education Minimum Requirements: B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology). Required Experience and Skills: Two (2)+ years of experience in Quality System Management. Strong CAPA and investigation experience. Reliance review experience. Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, interpersonal and conflict resolution skills. Ability to manage multiple priorities and projects simultaneously. Attention to detail, flexibility, and an awareness of quality problems. Preferred Experience and Skills: Experience in Pharmaceutical/Biological or related industry in quality control, quality assurance, manufacturing, or distribution. Knowledge of 9CFR and 21CFR requirements for product distribution and quality systems. Knowledge of Cold Chain Management within the global supply chain. Knowledge of SAP. Eight step problem-solving. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.