Senior Technician, Quality Assurance

Job description

Job Description 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. 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. Responsibilities of the role include the following: 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. Education Minimum Requirements: High school diploma or GED with 5 years relevant work experience. Preference given for AS or BS degree Position Qualifications: 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 Preferred: 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. #MSJR Required Skills: Aseptic Manufacturing, 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 {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts 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. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/21/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.