Associate Specialist, Quality Assurance

Merck•De Soto, KS

2d•Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. This role will primarily support Manufacturing Operations and will serve as the Quality Integrated Process Team (IPT) Representative for the Fermentation and Downstream and Single Use Bioreactors (SUBs) manufacturing areas. This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally. Primary responsibilities include: Quality Integrated Process Team (IPT) Representative Review and Approve Fermentation / Downstream and SUBs batch records. Provide generalist Quality support directly to production Prepare batch record documentation and perform review for compliance to ensure good documentation practices against established SOPs/standards. Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP. Resolves major issues that are not defined by SOP. Quality representative in daily Tier 1 meetings Collaborates with IPT members in the identification and implementation of continuous improvement actions. Provide seeds for the departments to initiate scale up processes. Serve as backup for other assigned areas assigned by QA management Support with document filing and archival Resolves major issues that are not defined by SOP. Deviation management/CAPA Author or support in investigations for determination of root cause and impact assessment Assess, review, and area approve assessment of impact to recommend disposition of any impacted products Support with classifications and reviews for events & CAPA. Completes Corrective Action and Preventive Action as assigned Performs follow up for Corrective Action and Preventive Action completion Change management Support, track and assure completion of change control documentation Completes change control action items as assigned Performs review and approval of change controls as a Quality Representative in Quality Assurance Assist with revising existing documents and procedures. Creates and updates Quality Assurance procedures as needed. Inspection Readiness Conduct monthly Quality Gemba walks within the departments, assists in prioritization and execution of Quality Compliance actions assigned to the area. Conduct and maintain Inspection readiness across the site. Support with Animal Health Quality Manual updates for Self-Inspection as Site System owner or Subject Matter Expert. Training Completes all training by assigned due date Crosstrain on other functions within the Quality Assurance department Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role. A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Requirements

Associate’s Degree with 5 years of relevant industry experience required.
Bachelor’s Degree required, degree in the sciences preferred.
Minimum of two years of Quality experience in a regulated industry.
Strong communication skills both written and verbal.
Experience with investigations, risk assessment, and regulatory inspections.
Skilled in technical writing.
Candidates have experience in SAP, Aera and Reliance or similar systems.
Excellent attention to detail
Takes decisions with minimal supervision by defined processes and the knowledge to escalate for management review when required.
Exceptional problem-solving skills to identify logical solutions to challenges

Nice To Haves

Familiarity and/or experience with vaccine manufacturing and testing.
Strong Microbiology background
Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual.
Project Management experience.

Responsibilities

Quality Integrated Process Team (IPT) Representative
Review and Approve Fermentation / Downstream and SUBs batch records.
Provide generalist Quality support directly to production
Prepare batch record documentation and perform review for compliance to ensure good documentation practices against established SOPs/standards.
Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
Resolves major issues that are not defined by SOP.
Quality representative in daily Tier 1 meetings
Collaborates with IPT members in the identification and implementation of continuous improvement actions.
Provide seeds for the departments to initiate scale up processes.
Serve as backup for other assigned areas assigned by QA management
Support with document filing and archival
Resolves major issues that are not defined by SOP.
Deviation management/CAPA
Author or support in investigations for determination of root cause and impact assessment
Assess, review, and area approve assessment of impact to recommend disposition of any impacted products
Support with classifications and reviews for events & CAPA.
Completes Corrective Action and Preventive Action as assigned
Performs follow up for Corrective Action and Preventive Action completion
Change management
Support, track and assure completion of change control documentation
Completes change control action items as assigned
Performs review and approval of change controls as a Quality Representative in Quality Assurance
Assist with revising existing documents and procedures. Creates and updates Quality Assurance procedures as needed.
Inspection Readiness
Conduct monthly Quality Gemba walks within the departments, assists in prioritization and execution of Quality Compliance actions assigned to the area.
Conduct and maintain Inspection readiness across the site.
Support with Animal Health Quality Manual updates for Self-Inspection as Site System owner or Subject Matter Expert.
Training
Completes all training by assigned due date
Crosstrain on other functions within the Quality Assurance department