Quality Assurance & Compliance Specialist

Apex Systems; Phoenix (AZ); On-site; USD 40,000 - 45,000; Part time

Job summary

Apex Systems is seeking a Quality Control Specialist in Phoenix, AZ to support in-house testing during manufacturing to ensure products meet quality standards. The role involves sampling, microbial testing, ATP assessments, and rigorous documentation practices under the Quality Manager.

You will help close out MBRs/MPRs, assist with SOP creation, and contribute to internal audits while ensuring compliance with cGMP and 21 CFR 111.

Qualifications

• 2+ years in a cGMP industrial environment.
• Training in Quality Systems.
• Nutraceutical background and dietary supplements experience preferred but not required.
• Strong knowledge of 21 CFR 111 and auditing processes.
• Excellent written, problem-solving, time-management, and verbal communication skills.
• Proven track record of over-achieving goals or going above and beyond.
• Willingness to learn.
• Working knowledge of the CAPA process.
• Strong knowledge and experience in document control processes and procedures.

Responsibilities

• In-house microbial testing by 3M Petrifilm.
• ATP testing and production process approval.
• Collecting and preparing finished-good samples for potency, heavy metal, and microbial testing for internal or third-party lab testing.
• Closing out MBRs and MPRs.
• Assisting the QC Manager and QA Specialist with documentation procedures and implementation.
• Monthly internal audits.
• Ensuring all employees follow cGMP and other necessary regulations.
• Identifying product defects.
• Investigation and reporting of production issues.
• Writing and issuing non-conforming reports.
• Assisting with SOP writing, review, and implementation.
• Conducting product assessments.
• Logging and storing all finished-good retention samples.

Skills

cGMP environment experience

Quality Systems training

Dietary supplements background

21 CFR 111 knowledge

Written and verbal communication

Problem-solving and time-management

CAPA process knowledge

Document control processes

Job description

Apex Systems is seeking a Quality Control Specialist in Phoenix, AZ to support in-house testing during manufacturing to ensure products meet quality standards. The role involves sampling, microbial testing, ATP assessments, and rigorous documentation practices under the Quality Manager.

You will help close out MBRs/MPRs, assist with SOP creation, and contribute to internal audits while ensuring compliance with cGMP and 21 CFR 111.