The Manufacturing Specialist performs duties to support the manufacturing, packaging, and delivery of Mo-99 to NorthStar’s customers while complying with procedures, instructions and prescribed routines. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agency standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Will participate in the various aspects of the Mo-99 production process, including pre-production set-up, manufacturing processes, and post production shut down activities.
2. Perform routine quality assurance testing of equipment prior to production.
3. Assist in the preparation and completion of various cGMP documents related to Mo-99 production, including Batch Records, Forms, Log Books, etc.
4. Perform order entry using company’s Enterprise Resource System.
5. Perform operational checks of equipment and record data from various environmental monitoring devices.
6. May perform quality assurance testing for Mo-99 batch production under the direction of the Director of Manufacturing. Tests may include use of a Germanium Detector system, thin layer chromatography, use of a dose calibrator, pH meter and other analytical equipment as needed.
7. Will assist in the proper disposal of radioactive wastes into appropriate shielded containers for decay-in-storage, under the direction of MURR Health Physics rules.
8. May assist in activities to prepare products for delivery, including assembling packaging.
9. Assist to maintain the facility and cleanliness of the production areas pursuant to 21 CFR Part 210 and 211 and NorthStar’s cleaning policies and procedures.
10. Receive packages and restock inventory. May participate in inventory management and place orders for products under the direction of the Director of Manufacturing.
11. Perform or assist with operations, as required, to maintain workflow and to meet schedules and quality requirements. Notify supervisor of unusual equipment or operating problems and the need for additional material and supplies.
12. Maintain safe work area and comply with safety procedures and equipment operating rules keeping work area in a clean and orderly condition. Handling of production and laboratory chemicals is required when performing specific duties. Any chemicals are to be handled in a safe manner with appropriate attention to following procedures and wearing protective garb.
13. Participate in any variety of meetings and work groups to integrate activities, communicate issues, obtain approvals, resolve problems and maintain specified level of knowledge pertaining to new developments, requirements, policies, and regulatory guidelines;. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
14. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
15. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelors or Technical Degree in science, technology, engineering and one or more years of experience in a cGMP manufacturing environment; or equivalent combination of education and experience.
Proficient knowledge of Microsoft Office software programs including Outlook, Word, and Excel.
• Ability to work long (>8 hours) and unusual hours to include third shift, weekends and holidays.
• Excellent communication skills, verbal and written
• Detail oriented and very organized
• Effective time management skills
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently
• Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line