Merck
Associate Specialist, Quality Systems & Compliance
Merck, Worthington, Minnesota, United States, 56187
Quality Assurance Specialist
Responsibilities: Under general supervision, this position assists with: Maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines and site procedures Processing document change controls Management of the site's Finished Product Samples Inventory including retention management and submission to the CVB Inspection, review and release of incoming raw materials for production, ensuring compliance with regulatory and site requirements for use Coordinating with site stakeholders and third-party vendors to maintain supply chain records, provide information for supplier audits, and manage incoming supplier change controls for site review. Reviewing documents against regulatory requirements for compliance and updates as required Maintaining and operating within critical quality systems such as change control, document management, deviation management, etc. Review of batch records and test records Maintenance of seed stocks Performing disposition and movement transactions in SAP Annual outline review management Provides direct support during audits and regulatory inspections Supports vendor audits Conducts/participates in self-inspection audits Assists with special projects, such as Quality Work Plans Assists with external audits if required Uses electronic programs such as Word and Excel to create and maintain official controlled documents managed by the QA department Performs general QA activities including but not limited to: Organization and accurate filing of controlled documents Cleaning of QA areas, as needed Performs other activities in support of the Quality Department and site, as needed Education Minimum Requirements: High school diploma or equivalent with 7 years relevant work experience and skilled at verbal and written communication Prefer Bachelor's degree in a related field with at least 2 years relevant work experience or a non-related Bachelor's degree with some relevant experience or Associate's degree in a related field with 5 or more years of experience Required Experience: Ability to work successfully in a team-oriented environment and coordinate multiple tasks Ability to work independently with minimal direct supervision Ability to effectively follow Standard Operating Procedures and other procedural guidelines Ability to manage multiple projects simultaneously and produce timely results Strong organizational skills with close attention to detail Strong computer skills with MS Office environment experience Excellent communication and writing skills Ability to communicate effectively with all levels of colleagues between multiple departments Willing to travel up to 5% Preferred Experience: Previous experience with USDA or GMP manufacturing environment and/or quality systems highly preferred Previous experience with SAP inventory management systems Experience or knowledge of Lean process initiatives, 6-Sigma or similar programs Salary Range: $63,900.00 - $100,500.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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. You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. Employee Status: Regular Relocation: No VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Business, Business, cGMP Regulations, Communication, Documentation Systems, Document Management, Employee Retention Management, GMP Compliance, Good Manufacturing Practices (GMP), IS Audit, Maintenance Management, Management Process, Manufacturing Compliance, Manufacturing Environments, Multi-Management, Product Handling, Project Management, Raw Material Procurement, Raw Materials, Regulatory Compliance, Regulatory Requirements, SAP Inventory Management, SAP Quality Management (QM), SAP SCM (Supply Chain Management), SAP Warehouse Management System (WMS) {+ 5 more} Preferred Skills: Job Posting End Date: 08/15/2025 Requisition ID: R346966
Responsibilities: Under general supervision, this position assists with: Maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines and site procedures Processing document change controls Management of the site's Finished Product Samples Inventory including retention management and submission to the CVB Inspection, review and release of incoming raw materials for production, ensuring compliance with regulatory and site requirements for use Coordinating with site stakeholders and third-party vendors to maintain supply chain records, provide information for supplier audits, and manage incoming supplier change controls for site review. Reviewing documents against regulatory requirements for compliance and updates as required Maintaining and operating within critical quality systems such as change control, document management, deviation management, etc. Review of batch records and test records Maintenance of seed stocks Performing disposition and movement transactions in SAP Annual outline review management Provides direct support during audits and regulatory inspections Supports vendor audits Conducts/participates in self-inspection audits Assists with special projects, such as Quality Work Plans Assists with external audits if required Uses electronic programs such as Word and Excel to create and maintain official controlled documents managed by the QA department Performs general QA activities including but not limited to: Organization and accurate filing of controlled documents Cleaning of QA areas, as needed Performs other activities in support of the Quality Department and site, as needed Education Minimum Requirements: High school diploma or equivalent with 7 years relevant work experience and skilled at verbal and written communication Prefer Bachelor's degree in a related field with at least 2 years relevant work experience or a non-related Bachelor's degree with some relevant experience or Associate's degree in a related field with 5 or more years of experience Required Experience: Ability to work successfully in a team-oriented environment and coordinate multiple tasks Ability to work independently with minimal direct supervision Ability to effectively follow Standard Operating Procedures and other procedural guidelines Ability to manage multiple projects simultaneously and produce timely results Strong organizational skills with close attention to detail Strong computer skills with MS Office environment experience Excellent communication and writing skills Ability to communicate effectively with all levels of colleagues between multiple departments Willing to travel up to 5% Preferred Experience: Previous experience with USDA or GMP manufacturing environment and/or quality systems highly preferred Previous experience with SAP inventory management systems Experience or knowledge of Lean process initiatives, 6-Sigma or similar programs Salary Range: $63,900.00 - $100,500.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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. You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. Employee Status: Regular Relocation: No VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Business, Business, cGMP Regulations, Communication, Documentation Systems, Document Management, Employee Retention Management, GMP Compliance, Good Manufacturing Practices (GMP), IS Audit, Maintenance Management, Management Process, Manufacturing Compliance, Manufacturing Environments, Multi-Management, Product Handling, Project Management, Raw Material Procurement, Raw Materials, Regulatory Compliance, Regulatory Requirements, SAP Inventory Management, SAP Quality Management (QM), SAP SCM (Supply Chain Management), SAP Warehouse Management System (WMS) {+ 5 more} Preferred Skills: Job Posting End Date: 08/15/2025 Requisition ID: R346966