Senior Technician, Quality Systems & Compliance

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.

The candidate will audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents as required. This will include Batch Record reviews per cGMP as required. Manage short-dated inventory. Final compliant stock will be released for Distribution. Maintain completed inspection files.

Adherence to medical product Cold Chain requirements will be addressed buy this candidate via on-line data downloading.

The candidate will be responsible to perform physical inspections of incoming finished products, and approved artwork per AQL (Acceptable Quality Level) inspections.

Manage site Notification of Events (NOE) and Product Quality Complaints within the company's Reliance system, as required. Perform NOE follow-up and completion through investigations, Corrective Actions, Preventative Actions, etc., as applicable. Assist in self-inspection audits for the Omaha Distribution Center.

The candidate Must have experience with cGMP/GDPs and have understand Data Integrity requirements.

Other Quality Assurance duties and projects will be assigned as applicable.

• High school diploma required.
• BS or BA degree in Biology or related science highly preferred.

• 3-5 years Quality Assurance / Quality Control experience.
• Basic knowledge of USDA, FDA, DEA, and /or EPA requirements.
• Must have good planning and organization skills to handle multiple projects.
• Strong communications skills.
• Technical writing skills.
• Ability to assume technical responsibilities with minimum supervision.

• Aseptic Manufacturing
• Aseptic Manufacturing
• Biological Sciences
• Biopharmaceuticals
• Consulting
• Corrective Action Management
• Data Integrity
• FDA Compliance
• FDA Regulations
• Inventory Management
• Manufacturing Audits
• Materials Inspection
• Medical Device Management
• Medical Devices
• Microbiology
• Operational Quality
• Pilot Plant Operations
• Preventive Action
• Process Improvements
• Project Management
• Quality Assurance Processes
• Quality Improvement Programs
• Quality Management Systems (QMS)
• Quality Process Development
• Quality Standards {+ 1 more}

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.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions;

facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

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.

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…