Jobs 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.

Supports marketing initiatives across social media, email, website, surveys, product launches, trade shows, and digital and print campaigns. Responsibilities include managing LinkedIn content calendars, executing HubSpot email campaigns, updating WordPress pages, analyzing surveys and engagement, preparing product photography, creating Canva graphics, and maintaining consistent brand standards. The role collaborates cross-functionally and reports to the Product Marketing Manager.

Leads molecular quality control release testing for DNA and RNA products, including assay execution, statistical analysis, troubleshooting, trend review, investigations, CAPA, SOP development, and product transfers from R&D. Mentors staff, coordinates testing schedules and materials, supports customer complaint evaluations, maintains contamination-controlled laboratory practices, and ensures compliance with cGMP and certified quality systems.