The Quality Assurance (QA) Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with company policies and procedures.

PRINCIPAL RESPONSIBILITIES:

• Write, revise, review, and approve site procedures and policies.
• Review and approve investigations and associated CAPAs, Change Controls and nonconformance.
• Participates in regulatory agency (i.e., FDA, etc.) inspections.
• Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.
• Assemble, analyze, and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Review Batch Records and provide final product disposition.
• Conducts internal audits of GMP Quality Systems and sub systems.
• Aide in assessing risk during Supplier Qualifications or Material Assessments.
• Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
• Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications by conducting incoming material disposition.
• Reviews and assesses in-house solution preparation and external material testing.
• Document Control, Training, Quality Systems back-up, and key trainer for conducting GMP training.
• May assist in conducting Supplier Qualification and reviews.
• Ensure manufacturing and analytical equipment is appropriately maintained and calibrated.
• Performs other duties as assigned.

MIMIMUM QUALIFICATIONS:

• Bachelor’s degree in Life Sciences or related field required.
• 5 or more years of relevant experience required.
• 5 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry preferred.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes, and facility systems.
• Must have full understanding of pharmaceutical change control.
• Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
• Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Engineering, Operations, Research and Development teams.
• Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred.
• Working knowledge of Adobe editing software strongly preferred
• Working knowledge of working in hybrid QMS system (paper/electronic)
• Demonstrated ability to manage timelines and priorities.
• Demonstrated ability to work independently with minimum guidance.
• Demonstrated ability to multi-task and focus attention to detail.
• Knowledge of how and ability to write, review, and revise Standard Operating Procedure (SOPs).

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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Rochester, MN 55902: Relocate before starting work (Required)

Work Location: In person