Quality Specialist

Burke Porter, an Ascential Technologies Company; Ham Lake (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Quality Specialist to support quality functions through systems development, document review, and compliance with regulations. The role requires collaboration across teams, strong communication skills, and a commitment to quality standards. Ideal candidates will have a high school diploma and relevant experience in a regulated environment, with opportunities for professional growth.

Qualifications

• Five years of related experience or training in regulated industry.
• Knowledge of medical device regulations (21CFR820, ISO 13485).
• Ability to prioritize tasks and accomplish results independently.

Responsibilities

• Support quality functions through quality systems development and improvement.
• Assist in management of quality issues and offer input representing quality assurance.
• Create and issue batch documentation and perform quality review of batch records.

Skills

Analytical skills

Communication

Collaboration

Time management

Problem-solving

Education

High school diploma or equivalent

Tools

Microsoft applications

Job description

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Summary

The Quality Assurance (QA) Specialist supports the quality functions through quality systems development and improvement, document and records review, auditing, and other quality functions. The QA Specialist will understand and follow appropriate quality procedures to meet compliance standards, including ISO 13485, 21CFR211and 21CFR820.

• Participate in cross-functional team meetings as a quality representative, assist in management of quality issues and offer input representing quality assurance (new product design, data reviews or root cause investigations).
• Work collaboratively with all functions to ensure understanding and conformance with quality requirements.
• Assist in Quality review of newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness and/or author documents as needed.
• Create and issue batch documentation (i.e. Batch records, labels, line clearance)
• Perform Quality review of batch records for product manufacturing
• Create and review DHR’s and supporting documentation.
• Perform Quality disposition of product/materials.
• Responsible for customer interaction on all quality issues/concerns and compliance related activities.
• Assist in maintaining and/or developing companywide Quality systems including, but not limited to, quality audits, product validation, document control, acceptance activities, production and process control, and corrective and preventive action.
• Propose process improvements and areas for improvement to supervisor.
• Assist with conducting review of raw materials, intermediates, and finished goods to ensure specifications and quality standards are met when required.
• Conduct inspection of product literature and labels to ensure accuracy.
• Performs additional duties as assigned.
  
  

Summary

The Quality Assurance (QA) Specialist supports the quality functions through quality systems development and improvement, document and records review, auditing, and other quality functions. The QA Specialist will understand and follow appropriate quality procedures to meet compliance standards, including ISO 13485, 21CFR211and 21CFR820.

Essential Responsibilities

• Participate in cross-functional team meetings as a quality representative, assist in management of quality issues and offer input representing quality assurance (new product design, data reviews or root cause investigations).
• Work collaboratively with all functions to ensure understanding and conformance with quality requirements.
• Assist in Quality review of newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness and/or author documents as needed.
• Create and issue batch documentation (i.e. Batch records, labels, line clearance)
• Perform Quality review of batch records for product manufacturing
• Create and review DHR’s and supporting documentation.
• Perform Quality disposition of product/materials.
• Responsible for customer interaction on all quality issues/concerns and compliance related activities.
• Assist in maintaining and/or developing companywide Quality systems including, but not limited to, quality audits, product validation, document control, acceptance activities, production and process control, and corrective and preventive action.
• Propose process improvements and areas for improvement to supervisor.
• Assist with conducting review of raw materials, intermediates, and finished goods to ensure specifications and quality standards are met when required.
• Conduct inspection of product literature and labels to ensure accuracy.
• Performs additional duties as assigned.
  
  

EXPECTATIONS

• Follows applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
• Perform duties following company quality and safety standards.
• Participate in team building, training, and department communications.
• Maintain a high level of personal and professional integrity.
• Perform additional job responsibilities as assigned.
  
  

Qualifications

Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications.

Required:

• Must have a high school diploma or equivalent.
• Five years of related experience or training; or equivalent combination of education and experience in regulated industry.
• Ability to prioritize tasks and accomplish results independently
• Proficient computer skills including Microsoft applications
• Knowledge of medical device regulations (21CFR820, ISO 13485).
• Ability to establish credibility and build strong collaborative relationships internally and externally.
• Possess strong written and verbal communication skills and demonstrated ability to effectively communicate with a wide-ranging audience.
• Cross functional collaboration skills needed to foster alignment.
• Ability to prioritize and deliver on key initiatives; demonstrated success in achievement of key performance metrics targets within time and budget constraints.
• Ability to effectively train and educate stakeholders, partners, and management on aspects of the QMS.
• Strong analytical and critical thinking skills.
• Excellent organization and time management skills with an ability to think proactively and prioritize work.
• Ability to adapt to changing priorities and direction
  
  

Preferred:

• Working knowledge of FDA (21CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.
• Pharmaceutical or medical device industry experience
• Change Control
• Root Cause Analysis

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Government Administration

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