Quality Assurance Technician II

TEKsystems; Charleston (SC); On-site; USD 85,000 - 90,000; Full time

Job summary

TEKsystems is seeking a Quality Assurance Specialist II to support and execute core quality system processes in a cGMP manufacturing environment. You will focus on supplier quality management, audits, CAPA coordination, and quality systems oversight, collaborating with Procurement, Engineering, Quality, and Manufacturing.

The role requires a Bachelor's degree with 4+ years in regulated settings, strong knowledge of cGMP, and hands-on supplier audit experience.

Qualifications

• Bachelor's degree + 4+ years of quality or supplier management experience.
• Deep knowledge of cGMP, FDA expectations, and regulatory compliance.
• Experience with supplier audits, CAPA, change control, and nonconformance.

Responsibilities

• Manage supplier relationships and ensure quality requirements.
• Conduct on-site and remote supplier audits.
• Coordinate CAPA, change control, and nonconformance processes.
• Lead supplier qualification and maintain approved supplier lists.
• Investigate product complaints and support regulatory inspections.
• Review SOPs and drive continuous quality improvements.
• Collaborate with Procurement, Engineering, Quality, and Manufacturing.

Skills

Regulated Manufacturing

Supplier Quality & Audits

Cross-Functional Collaboration

Education

Bachelor's degree + 4+ years experience

Job description

Description

The Quality Assurance (QA) Specialist II is responsible for supporting and executing core quality system processes within a cGMP-regulated manufacturing environment. This role focuses heavily on supplier quality management, audit execution, CAPA coordination, and quality systems oversight.

Key responsibilities include:

• Managing supplier relationships and ensuring compliance with quality requirements
• Conducting supplier audits (on-site and remote)
• Supporting CAPA, change control, and nonconformance processes
• Leading supplier qualification and maintaining approved supplier lists
• Investigating product complaints and coordinating corrective actions
• Supporting regulatory inspections and internal audits
• Reviewing SOPs and maintaining compliance with cGMP standards
• Driving process improvements and quality initiatives across teams

This individual will collaborate with cross-functional teams including Procurement, Engineering, Quality, and Manufacturing to ensure product quality and regulatory compliance.

Required Skills & Qualifications

1. Regulated Manufacturing Experience

• Experience in dietary supplements, nutraceuticals, pharmaceuticals, or similar regulated industries
• Strong understanding of cGMP (Current Good Manufacturing Practices), quality systems, and compliance standards
• Hands-on work in regulated environments (pharma, biotech, medical device, etc.)

2. Supplier Quality & Audit Management

• Ownership of supplier quality programs and supplier relationships
• Experience conducting supplier audits (on-site and remote)
• Managing CAPA (Corrective and Preventive Actions) lifecycle, supplier qualification, and compliance oversight

3. Communication & Cross-Functional Collaboration

• Strong verbal and written communication skills
• Ability to work cross-functionally with Procurement, Engineering, Manufacturing, and Quality teams
• Clearly present audit findings, compliance updates, and quality initiatives

Additional Skills and Qualifications

• Bachelor's degree + 4+ years of relevant experience OR equivalent
• Strong understanding of cGMP, FDA, and regulatory compliance
• Experience working with contract manufacturers and suppliers
• Excellent communication and documentation skills
• Ability to work independently and manage multiple priorities
• Willingness to travel up to 50%

Job Type & Location

This is a Permanent position based out of Charleston, SC.

Pay and Benefits

The pay range for this position is $85000.00 - $90000.00/yr.

• Full Benefits - Medical, Dental, Vision, 401k Match, etc

Workplace Type

This is a fully onsite position in Charleston,SC.

Application Deadline

This position is anticipated to close on Aug 21, 2026.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.