Production Technician
The Production Technician has primary responsibility for production of in-vitro medical diagnostic products in accordance with current manufacturing directions, SOPs, GMPs, and QSR to meet or exceed quality specifications on schedule at or below standard costs. Identify areas, formulate and execute plans for manufacturing process quality and efficiency improvements. Work in collaboration with Manufacturing, Quality Systems, Technical Support, Sales and Marketing to ensure product quality and availability.
GENERAL RESPONSIBILITIES:
- Maintain accurate records in accordance with current SOPs and cGMP.
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Understand and apply the concepts of aseptic technique.
- Correctly read and interpret detailed production procedures.
- Comply with all OSHA and Quality system requirements.
- Accurate, timely and complete documentation in conformance with regulatory policies and standards to meet quality requirements.
- Makes and records observations as needed and completes all necessary calculations in compliance with GMP requirements.
- Train other employees as required.
- Audit own paperwork daily for corrections, missing, and/or incomplete information.
- Immediately identify any deviation from production procedures and notify the appropriate Supervisor/Manager/Director.
- Recognize and evaluate ways to improve procedures and products.
JOB-SPECIFIC RESPONSIBILITIES:
- Ensure an adequate supply of antigens, antisera and other in-house produced materials to meet production needs (prepare, test, trouble-shoot).
- Perform technical procedures including preparation of buffers/reagents in accordance with manufacturing directions following current SOPs, GMPs, and QSRs.
- Set up, perform, and accurately interpret in-process testing of buffers/reagents/components. Assist in troubleshooting non-conforming results to determine root cause.
- Conducts laboratory support functions, such as monitor and requisition or initiate in-house production of raw materials and supplies required to meet production schedules and collecting/washing/storing glassware.
- Complete incoming testing analysis for components where needed to ensure acceptability per quality guidelines prior to use in production.
- When working in the Molecular department:
- Dispense, package, and inspect reagents and products in accordance with manufacturing directions following current SOPs, GMPs, and QSRs.
- Operate, maintain and clean ISO Classified clean rooms and related equipment in accordance with SOPs
- When working in Purification department
- Responsible for the isolation, purification, and characterization of proteins from recombinant and natural sources.
- Perform routine calibrations and complete calibration records in Blue Mountain, as needed.
- Initiate OOS's, Deviations, and ECO's as needed with minimal supervision.
EDUCATION/EXPERIENCE:
- Bachelor’s degree in Molecular Biology, Microbiology, Biochemistry, or similar degree required.
- Experience in a FDA-regulated manufacturing, or laboratory environment is desirable.
- Previous course work in immunology, microbiology cell biology, biochemistry, virology and chemistry is desirable.
SKILLS, SPECIALIZED SKILLS AND ABILITIES:
- Preferred skills include Cell culture, Virus culture, Bacteriology, Protein purification and conjugation, Microscopy, experience with Laboratory equipment including Spectrophotometer pH meter, centrifuges, column chromatography, and performing diagnostic assays.
- Communication skills include: ability to interact with Manufacturing and Quality function; clearly inform supervisory personnel regarding status of projects; and establish and follow target date scheduling and reporting procedures.
- Aseptic technique, general laboratory techniques and metric system knowledge required.
- Excellent documentation skills as required by cGMPs on a timely basis.
- Ability to read, understand and follow all company SOPs and guidelines.
- Must be a self-starter, detail oriented, organized, prioritize and balance workloads and timelines and be able to perform under pressure in a fast-paced environment.
- Ability to maintain regular attendance and punctuality requirements
- Must be able to work hours outside of the normal work day (start early, stay late or weekends) to support department activities.
- Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
- Computer proficient in Microsoft Office programs. Experience in technical writing (GMP documents, protocols, reports, etc) a plus.