Quality Assurance Associate

Nucleusrad; Rochester (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing industry seeks a Quality Assurance Associate to support their Quality Management System. This entry-level position focuses on quality systems activities including CAPA coordination and training material development. Candidates should possess a Bachelor's degree and 0-2 years of experience in a GMP-regulated environment.

Benefits

Medical, dental, and vision insurance

Health Savings Account or Flexible Spending Account

401k retirement account access with employer matching

Paid sick leave and paid time off

Qualifications

• 0-2 years of experience in a GMP-regulated environment required.
• Familiarity with QMS functions such as deviations, CAPAs.
• Experience with document formatting and editing preferred.

Responsibilities

• Assist in managing QMS processes, including deviations and CAPAs.
• Support document control and change control activities.
• Prepare training materials and ensure audit readiness.

Skills

Attention to Detail

Organizational Skills

Communication Skills

Education

Bachelor's degree in Life Sciences, Quality, or a related field

Tools

Microsoft Office

QMS Systems (Dot Compliance, Veeva, etc.)

Job description

Join to apply for the Quality Assurance Associate role at Nucleus RadioPharma

Join to apply for the Quality Assurance Associate role at Nucleus RadioPharma

The Quality Assurance (QA) Associate will support the execution and maintenance of our Quality Management System (QMS). This role focuses on quality systems activities including deviation and CAPA coordination, change control tracking, and document control support. They will also assist in the creation of training materials to support GMP and quality compliance initiatives.

Description

Key Responsibilities:

• QMS Support:
• Assist in the day-to-day management of QMS processes, including deviations, CAPAs, and change control documentation.
• Ensure quality records are accurate, complete, and compliant with applicable regulatory requirements.
• Deviation and CAPA Support:
• Help with the initiation, investigation tracking, and closure of deviations and CAPAs.
• Monitor timelines and follow up on overdue items to ensure compliance and effectiveness of corrective actions.
• Change Control Coordination:
• Support change control activities by reviewing forms, tracking implementation steps, and verifying completion of required tasks.
• Document Control Backup:
• Provide backup support to Document Control, including issuing, revising, and archiving controlled documents in accordance with internal procedures.
• Assist with formatting and ensuring documentation aligns with internal standards and regulatory expectations.
• Training Document Development:
• Assist in the creation and revision of quality training materials, such as SOP overviews, quick reference guides, and onboarding materials.
• Collaborate with quality and operational teams to ensure training documents are clear, effective, and aligned with current procedures.
• Audit and Inspection Readiness:
• Assist with audit preparation activities, including collecting quality system records and ensuring documentation is audit-ready.
• Participate in post-audit follow-up by helping compile responses and corrective actions.
• Performs other duties as assigned.
  
  

Qualifications And Requirements

• Bachelor’s degree in Life Sciences, Quality, or a related field preferred (or equivalent
  
  

Experience) Required.

• 0–2 years of experience in a GMP-regulated pharmaceutical, biotech, or medical device environment required.
• Familiarity with QMS functions such as deviations, CAPAs, change control, and document control required.
• Excellent attention to detail, organizational, and communication skills.
• Proficiency in Microsoft Office; experience with electronic and or manual QMS systems (e.g., Dot Compliance, Veeva, MasterControl, TrackWise) is a plus.
• Experience with document formatting and editing for SOPs or training materials
  
  

preferred.

• Understanding of Good Documentation Practices (GDP) and GMP regulations (21 CFR Parts 210/211) preferred.
• Demonstrated ability to manage timelines and priorities.
• Demonstrated to work independently with minimum guidance.
• Demonstrated to multi-task and focus attention to detail.
• Knowledge of how and ability to write, review, and revise Standard Operating Procedure (SOPs)
• 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.
  
  

The Fine Print

The salary range in Minnesota is $28.00-34.00 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.

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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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