Quality Assurance Tech IV

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We want the best and brightest people to help us achieve our mission to develop and deliver life‑enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

The Quality Assurance Technician IV provides high‑level administrative support, acts as a lead or mentor to junior personnel, works independently and often without established procedures, and is a key decision maker in the release function of product. This role coordinates with various departments to meet shipping schedules and possesses extensive knowledge of products, raw materials, inventory planning, quality, manufacturing, and quality systems.

• Serve as a leader in QA to facilitate the release of API, DP, ARS, intermediates, and clinical supplies, keeping the release function on track with the shipping schedule.
• Manage all aspects of the release process by engaging QA Tech II/IIIs for status, ensuring resolution and prioritization per shipping schedule.
• Serve as the primary contact for inquiries and scheduling in the primary value stream.
• Point person for executing material release, status changes, or location changes for manufacturing / logistics and stability.
• Participate on cross‑functional teams (Quality Control, Manufacturing, Marketing, & Logistics) to ensure that product/material conforms to customer, industry, & regulatory standards prior to release.
• Expert knowledge of BPCS and LIMS.
• Supply certificate of analysis to customer service/shipping personnel.
• Work with production in recording correct DOM.
• Serve as a resource regarding batch record linkage for all special products.
• Prepare shipping schedule and attend meetings weekly.
• Mentor and provide training to QA Technicians in error types and issue resolution.
• Work across Value Streams (backup for other value streams).
• Update shipping and MREL/DREL spreadsheets.
• Run retest and expiry reports and send out lot isolation forms.
• Update items in BPCS for the in‑process lab personnel.
• Review batch records as a backup or if required for shipping needs.

HS Diploma is required;
Associates or Bachelor’s degree is preferred. A four‑year degree in a technical field may be considered toward the minimum experience requirement.

Minimum of 6‑8 years of document review and product release experience in a GMP environment is required. Proven knowledge of FDA and cGMP regulations is required.

Proficiency in MS Word and Excel. LIMS and BPCS experience required.

• Ability to communicate at a high level.
• Ability to read and comprehend complex calculations and formulas.
• Ability to focus and review batch records for an extended period of time.
• Knowledge of GMPs for APIs.
• Ability to quickly identify, communicate and/or resolve issues.
• Ability to read and understand complex batch records.
• Ability to keep batch records organized and easily retrievable at all times.
• Good verbal and written communication skills.
• Ability to understand and apply good documentation practices.
• Ability to communicate at a high level with various departments and individuals across the site.
• Ability to understand complex data, utilizing database and various systems to extract and revise data within the system.
• This role interacts with various individuals at all levels within the organization, must have the ability to prioritize requests and manage work to meet timelines.

Action Oriented, Patience, Planning, Priority Setting, Problem Solving, and Technical Learning.

Works with Manufacturing, Supply Chain, Research & Development, Customer Service, and Quality personnel on a daily basis.

• 95% office…