Specialist, Quality Assurance

Regulatory Jobs; Saint Joseph (MI); On-site; USD 60,000 - 85,000; Full time

Job summary

Regulatory Jobs seeks an experienced QA professional to contribute to the overall QA program of our laboratory. The role focuses on licensure, accreditation, and inspection readiness, with accountability for internal and external quality assurance.

This is an onsite position at 1234 Napier Ave supporting Corewell Health South Hospital Sites. Travel up to 25% is expected.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent experience.
• Minimum 2–3 years of technical laboratory experience.
• ASCP Certification preferred.

Responsibilities

• Oversee Proficiency Testing (CAP and NYS); maintain database and monthly summaries.
• Manage Document Control System and ensure compliance with policies.
• Promptly report and document Reportable Quality Issues and Revised Reports.
• Conduct internal audits to ensure readiness for inspections.
• Assist with external audits and prepare documentation.
• Review protocols and recommend QA program improvements.
• Coordinate regulatory compliance through documentation, audits, and corrective actions.
• Review departmental quality records and collaborate on nonconformances.

Skills

Leadership

Communication

Interpersonal skills

Detail-oriented

Organizational skills

Problem solving

Time management

Microsoft Office

Laboratory Information Systems

Education

Bachelor’s Degree BA/BS Life Sciences

Tools

Microsoft Office

Laboratory Information Systems

Job description

Contribute to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs.

This is an Onsite position at 1234 Napier Ave supporting our Corewell Health South Hospital Sites.

Travel: Up to to 25% or less.

• Manage Proficiency Testing Program (CAP and NYS) for the laboratory - maintain data base and produce monthly summaries.
• Manage the Document Control System. Support compliance with document control policies for all procedures and related documents.
• Assist in the prompt and complete reporting of Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP.
• Conduct internal audits to ensure laboratory is inspection ready at all times.
• Assist with external audits.
• Review protocols and make recommendations to enhance QA Program.
• Coordinate compliance with applicable regulations through documentation, audits, and corrective action.
• Perform reviews of departmental quality records. Collaborate with management in the testing department to investigate and resolve nonconformances.
• Audit training and competency program.
• Promote continuous quality improvement by collaborating with management to implement standardization and process improvement.
• Perform special projects as assigned.
• Perform other duties as assigned to meet the business needs or customer requirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.

Required Work Experience:

Minimum two (2) to three (3) years technical laboratory experience.

Preferred Work Experience:

Previous experience with Quality Assurance and laboratory regulations preferred.

Physical and Mental Requirements:

• The normal performance of duties may require lifting and carrying objects: Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to 25 pounds are lifted and carried occasionally; objects 36 to 50 pounds are seldom lifted or carried and objects over 50 pounds are not to be lifted or carried without assistance.
• Ability to sit or stand for long periods of time.

Knowledge:

• Basic theoretical and operational job knowledge in quality assurance and laboratory operations.
• Knowledge of organizational/departmental policies and procedures.

Skills:

• Demonstrate leadership skills through accountability, integrity, and collaboration in daily tasks.
• Excellent interpersonal and communication skills (oral and written) necessary to effectively interact with all levels of staff.
• Project a positive, professional demeanor.
• Communicate with employees in a manner that creates an informed, positive environment.
• Facilitate efforts to work with others in a way that promotes teamwork and change.
• Must be detail-oriented, have the ability to work independently, establish work priorities and to handle several tasks simultaneously.
• Strong organizational and prioritization skills.
• Proven problem-solving skills with the ability to develop appropriate resolutions.
• Proficiency in Microsoft Office (Word, Excel and Outlook) and Laboratory Information Systems.

Education

• Bachelor’s Degree BA/BS Degree in a Life Sciences preferred. Equivalent combination of education and experience. (considered)

Licenses and Certifications

• ASCP Certification (Preferred)