Teams at Maine Molecular Quality Controls, Inc.

Supports biotech manufacturing and QC teams through laboratory cleaning, glassware washing, autoclaving, inventory management, supply ordering, equipment accuracy checks, environmental monitoring, and housekeeping. Maintains electronic and physical inventory, follows SOPs, cGMP, ISO quality systems, PPE requirements, and good laboratory practices. The role requires organization, dexterity, attention to detail, physical stamina, and willingness to work in a controlled laboratory environment. Training is provided.

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.