Quality Assurance Specialist - Regulatory / Compliance (Up $4000, Entry Level)

RecruitFirst; Orchard (NE); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading recruitment agency is seeking entry-level candidates for a role in Lab/Biopharma/Clinical Research Testing in Orchard, Nebraska. The position involves ensuring compliance with regulations and corporate policies. Ideal candidates will have a degree in Life Science or Biotechnology and some related experience. Competitive salary and bonuses offered.

Qualifications

• Degree in Life Science or Biotechnology or equivalent.
• Prior experience (1-2 years) in Quality System & Assurance or GMP/GLP is advantageous.

Responsibilities

• Assist in performing validation activities for compliance.
• Participate in identifying recommendations for Quality Management.
• Perform internal and vendor audits.
• Analyze quality system metrics.
• Support regulatory inspections and client audits.
• Review and approve critical compliance documents.

Skills

Quality System & Assurance

Good Manufacturing Practice (GMP)

Analytical skills

Education

Degree in Life Science or Biotechnology

Job description

Up to $4000 + Annual Bonuses

Entry Level into Lab / Biopharma / Clinical Research Testing

Perm Employment

Job Details

• Working hours: Office Hours
• Location: East

Job Descriptions

• Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP).
• Understand the voice of the customer and participate in identifying recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management
• Perform internal and vendor audits, and review quality records to ensure compliance with regulations and corporate policies.
• Analyze quality system metrics and participate in continuous improvement initiatives and management reviews.
• Support regulatory inspections and client audits by preparing files and assisting with responses to findings.
• Review and approve critical documents like SOPs, protocols, and reports for accuracy and compliance.
• Provide regulatory support to operations and customers, including basic training and responding to inquiries.

Requirements

• Degree in Life Science or Biotechnology or equivalent
• Prior experience (1-2 years) Quality System & Assurance or GMP / GLP will be advantageous

We are an equal opportunities employer and welcome applications from all qualified candidates. We regret that only shortlisted candidates will be notified.