Teams at Maine Molecular Quality Controls, Inc.

Supports molecular diagnostics product development and validation through laboratory preparation, molecular biology testing, inventory management, documentation, and equipment operation. Performs plasmid purification, RNA transcription, nucleic acid extraction, PCR, and related assays under cGMP and ISO quality systems. Assists with Design Control and FDA 21 CFR 820 validation activities, organizes data, maintains laboratory cleanliness and supplies, and may work with pathogens in a BSL-2 environment.

Supports quality assurance and regulatory compliance within an ISO 13485 quality system. Reviews QMS documentation, investigates material review notifications, develops CAPA plans, authorizes process and equipment validations, assists with audits, maintains ISO certification, writes SOPs, and trains personnel. Requires experience in cGMP-regulated environments, strong attention to detail, communication skills, and the ability to manage priorities in a fast-paced diagnostic company.

The Manufacturing Process Engineer optimizes and automates biomanufacturing processes, troubleshoots equipment and production issues, and drives continuous improvement using LEAN and Six Sigma. Responsibilities include equipment selection, process scale-up, validation, process controls, CAPA, supplier corrective actions, SOP development, training, and regulatory compliance with cGMP, ISO, and FDA standards. The role collaborates with internal teams and vendors to improve manufacturing reliability, quality, safety, and efficiency.