POSITION SUMMARY:
The Quality Control (QC) Technician performs assigned laboratory testing in compliance with applicable standard operating procedures (SOPs) and in compliance with U.S. and international regulatory requirements, including FDA, ISO, USP, and NRC guidelines. The QC Technician adheres to current good manufacturing practices (cGMP) and good documentation practices (GDocP) for all analyses. Working collaboratively with other laboratory personnel, the QC Technician coordinates instrument usage and completes laboratory tasks efficiently. The QC Technician completes testing and promptly reports any aberrant results to quality management. They work independently under limited supervision and handle radioactive materials as part of their duties.
PRINCIPAL RESPONSIBILITIES:
- Ensure compliance with US and international regulatory agencies and guidelines.
- Perform analytical QC testing on radioactive materials using approved standard operating procedures.
- Ensure maintenance and calibration of laboratory equipment.
- Analyze standards and samples using various analytical instruments, including:
- HPLC/UPLC
- GC
- TLC
- pH meter
- FTIR
- Perform basic troubleshooting and maintenance of laboratory equipment failures.
- Assist management and QA with laboratory investigations by providing detailed information on test results and lab practices.
- Manage and maintain laboratory supply inventory.
- Collaborate with other QC team members to complete tasks within the established timelines.
- Review detailed test reports generated by other QC analysts, ensuring QC data is accurate, complete, and compliant with regulatory requirements.
- Ensure QC activities adhere to internal procedures, GMP, and regulatory requirements.
- Execute test method validation (TMV) protocols as required.
- Perform other daily responsibilities including:
- Maintaining lab cleanliness
Attending necessary quality and safety training sessions
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QUALIFICATIONS & REQUIREMENTS:
- Bachelor’s degree in chemistry, biology preferred; equivalent work experience may be considered.
- One (1) year of experience working in a cGMP regulated quality control laboratory preferred but not required.
- Proficiency with multiple analytical laboratory instruments, including HPLC, GC, FTIR, laboratory balance, and pH meter.
- Must be willing to wear a variety of personal protective equipment (PPE), including lab coats, gloves, safety glasses, and radiation dose monitors.
- Ability to support overnight schedules, including weekends and extended hours as needed, to support 24/7 manufacturing needs.
- Experience with laboratory information management systems (LIMS), chromatography software (e.g., Empower), and other QC data systems preferred.
- Adaptable to quickly changing priorities and environments.
- Experience with chemical and radiological laboratory safety (regulatory and best practices) is preferred.
- Strong attention to detail with the ability to maintain accuracy in laboratory analysis and documentation.
- Excellent problem-solving skills and the ability to troubleshoot independently.
- Strong written and verbal communication skills for cross-functional collaboration.
- Ability to work effectively both independently and within a team.
- Experience with method development and validation is preferred.
- Understanding of quality systems and regulatory expectations for analytical labs.
- Ability to foster an inclusive and cooperative work environment. Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands.
- Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.
- Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
- Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
- Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
- Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
- Normal near visual acuity (20/20 with or without corrective lenses) and no impairment of color vison.
Testing for visual acuity and color discrimination required.
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THE FINE PRINT:
The salary range in Minnesota is $20.00 – 33.00 per hour. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.
This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.
Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
