Senior Technician, Quality Systems & Compliance
EyeBio
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.
Required Education:
- High school diploma required.
- BS or BA degree in Biology or related science highly preferred.
Required Experience and Skills:
- 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.
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.
#MSJR
Required Skills:
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}Preferred Skills:
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U.S. Hybrid Work Model
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”.
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
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n/aJob Posting End Date:
03/10/2026*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.