Senior Technician, Quality Assurance

MSD•Worthington, MN

6d•Onsite

About The Position

Our Quality Assurance team works closely with Manufacturing Operations to ensure our products are made safely and to the highest quality standards. Working directly within our manufacturing plants, we embrace a "Safety First, Quality Always" mindset and are committed to continuous improvement. Through collaboration at the local plant level and across our global manufacturing network, we help ensure the highest quality standards for raw materials, intermediates, and finished products. The Senior Technician, Quality Documentation position is available at our Animal Health facility in Worthington, Minnesota. This site manufactures vaccines for large and companion animals and operates within a collaborative, innovative, and highly regulated environment. Key technologies at the facility include biologics production through fermentation and cell culture platforms, along with filling and freeze-drying operations. As part of the Quality team, you will help ensure the integrity of documentation systems that support the production of safe, effective, and high-quality animal health products.

Requirements

High school diploma or GED with 5 years relevant work experience.
Ability to work successfully in a team-oriented environment and coordinate multiple tasks.
Ability to work independently with minimal supervision
Ability to effectively follow Standard Operating Procedures and other procedural guidelines.
Strong organizational skills and attention to detail
Strong MS Office skills including Word & Excel
Good communication and writing skills.
Ability to communicate effectively with all levels of colleagues between multiple departments
Aseptic Manufacturing
Cell Cultures
Consulting
Corrective Action Management
Electronic Document Management System (EDMS)
FDA Compliance
Global Manufacturing
GMP Compliance
Mammalian Cell Culture
Manufacturing
Manufacturing Audits
Manufacturing Environments
Materials Inspection
Operational Quality
Pilot Plant Operations
Process Improvements
Quality Improvement Programs
Quality Management Systems (QMS)
Quality Process Development
Quality Standards
Quality Systems Documentation
Raw Materials
Standard Operating Procedure (SOP) Development
Standard Operating Procedure (SOP) Writing

Nice To Haves

AS or BS degree
Ability to successfully assume/complete additional responsibilities with little supervision.
Experience in document control, quality systems, or regulated manufacturing environments preferred.
Quality, Biology or Microbiology experience or knowledge preferred.

Responsibilities

Under general supervision, this position assists in maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines and site procedures.
Use of electronic programs such as Word, Excel, and SAP pertaining to Quality functions
Administer document control processes, including creation, review, approval, issuance, revision, and archival of controlled documents.
Maintain quality systems documentation such as Standard Operating Procedures (SOPs), work instructions, forms, and batch records.
Ensure documentation activities comply with GMP, regulatory requirements, and company quality standards.
Work with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Technical Operations, for document revisions.
Support document change control activities and ensure revisions are implemented accurately and on schedule.
Monitor documentation metrics and identify opportunities for process improvements.
Assist with internal and external audits, inspections, and regulatory requests by providing documentation and records as needed.
Maintain electronic document management systems (MEDS) and ensure document records are complete, accurate, and readily retrievable.
updates Organization, housekeeping and filing of site documents in QA areas, assist in maintenance and delivery of seed stocks.
Will perform other duties as assigned.