Quality Assurance Tech IV

Job Description Summary

The Quality Assurance Technician IV provides administrative support at a high level. They act as a lead or mentor to junior personnel and work independently with minimal supervision. This role serves as a key decision maker in the release function of product, coordinating with various departments to meet shipping schedules. Extensive knowledge of products, raw materials, inventory planning, quality, and manufacturing and quality systems is required.

• Serve as a leader in Quality Assurance to facilitate the release of API, DP, ARS, intermediates, and clinical supplies (R&D developed material) and keep the release function on track with the shipping schedule.
• Manage all aspects of the release process by engaging QA Tech II/III for status, ensuring resolution and priorities 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 product/material conforms to customer, industry, and regulatory standards prior to release.
• Expert knowledge/use 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, 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 required;
Associates or Bachelor's degree 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. Proven knowledge of FDA and cGMP regulations 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 timelines.

• Action Oriented
• Patience
• Planning
• Priority Setting
• Problem Solving
• Technical Learning

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

• 95% Office environment which includes sitting for long periods of time and computer use.
• 5% Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.