Career Opportunities at Mill Creek Life Sciences
Production Technician I (Jr.)
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.
TO APPLY: Please submit a Resume & Cover Letter to info@millcreekls.com
*Posted on 20 Jan 2021