QA Specialist

LPNA GROUP INC•Tonawanda, NY

2d•$60,000 - $65,000

About The Position

Lornamead is seeking a Quality Assurance Specialist to support and maintain its Quality Management Systems. The role is responsible for quality documentation and change management, finished-goods release documentation, calibration and training records, deviation coordination, centralized quality filing, and support for audits and other quality assurance activities.

Requirements

Bachelor’s degree with 1–2 years of experience, Associate’s degree with 3–4 years of experience, or 6+ years of equivalent experience in a QA role within a regulated industry.
Experience with Microsoft Word, Excel, Outlook, and Teams.
Ability to multitask and prioritize in a dynamic work environment.
Strong organizational, written, verbal, and presentation skills.
Ability to sit, stand, walk, and lift up to 30 pounds throughout an 8-hour shift.

Nice To Haves

Knowledge of FDA and Health Canada regulations for drugs and cosmetics.
Experience with an electronic document management system and/or electronic quality management system.

Responsibilities

Design, implement, and maintain Quality Assurance documentation and change management systems.
Issue, track, and control change controls, SOPs, Master Batch Records, Test Records, forms, protocols, amendments, and final reports, including formatting, editing, and revisions.
Create and maintain Certificates of Analysis (COAs) and other finished-goods release documentation; submit completed documents to the Quality Assurance Manager or designee for final approval.
Assist with contract customers’ quality assurance items, including documentation, COAs, CAPAs, and deviation updates.
Keep the calibration program updated and notify equipment owners so they can remain in compliance.
Maintain centralized Quality filing and lead the archiving process.
Coordinate deviations by processing nonconformities, issuing deviation numbers, and supporting on-time closures.
Support activities before, during, and after external audits and inspections, as required.
Analyze Quality function data to ensure site compliance.
Support quality assurance activities, including batch record review, quality checks, and incoming component and raw material checks.
Maintain the Training Matrix and support the training program, including employee training on cGMP, change control, and deviations.
Perform other tasks delegated by the Quality Assurance Manager.