Career Opportunities at Mill Creek Life Sciences

Position Overview

Production technician level l is responsible for end to end production; including pre-processing, processing, and post-processing in accordance with FDA GMPs and SOPs to comply with regulatory requirements and assist other groups including compliance.  The production technician l personnel are qualified by training, education, and experience to perform end to end processing defined manufacturing activities.

Essential Job Functions

• Clean equipment and maintain equipment following established SOPs and FDA GMP guidelines
• Validate equipment per established SOPs and FDA GMP guidelines
• Coordinate and stage materials and supplies for in production
• Complete documentation and maintain records
• Check in materials and supplies following established SOPs and FDA GMP guidelines
• Perform routine cleaning and maintenance of facility
• Performs pre-processing activities for product manufacturing in compliance with internally defined requirements and FDA GMP guidelines
• Prepares product for shipping following established SOPs and FDA GMP guidelines
• Performs facility monitoring in compliance with internally defined requirements and GMP guidelines
• Reports deviations and non-conformance to internally defined requirements and GMP requirements to MCLS leadership
• Perform manufacturing process using SOPs and FDA GMP guidelines
• Performs in research and development activities as designed by the Scientific Advisor
• Operates centrifuges, pH meters, conductivity meters, and other environmental monitoring
• Document according to SOPs and FDA GMP guidelines
• Weigh, measure and check raw materials to ensure batches meet release criteria

Non-essential Job Functions

• Attention to detail
• Adheres to high standard of personal and professional conduct
• Maintains confidentiality of sensitive oral, paper-based, and electronic information
• Complies with MCLS defined policies, processes, and procedures in the conduct of routine activities
• Maintains competency in FDA Good Manufacturing Practices
• Shares knowledge and information to assist in education and training MCLS staff
• Maintains and enhances profession/competency skills
• Maintains competency in FDA Good Manufacturing Practices

Requirements

• B.S in chemistry, biology or physical sciences or Medical Technologist/Medical Laboratory Technician (American Society of Clinical Pathologists) certification or equivalent,
• Must be capable of working in a clean room environment in clean room attire
• Must possess good communication skills and be able to work closely with others.
• Must be able to accommodate scheduling adjustments, off shifts, holiday, on-call, and weekend work assignments.
•  One year of experience is preferred as appropriate to assigned work area
• Previous FDA GMP experience preferred or willingness to complete course work within 3 months

Other Skills/Abilities

• Must be able to lift 40 pounds
• Must be able to work in clean room environment and clean room attire
• Good personal hygiene

NOTE:  This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.