Quality Assurance Technician

Express Employment Professionals - Cincinnati East; Homewood (AL); On-site; USD 36,000 - 44,000; Full time

Job summary

Asteria Health is seeking a Quality Assurance Technician to support Master Batch Record issuance and review, document control, and compliance initiatives in a fast-paced 503B outsourcing facility.

The role emphasizes strong technical writing, organization, and attention to detail while ensuring adherence to cGMP and FDA requirements. You will collaborate with cross-functional teams to maintain quality systems and archival processes.

Qualifications

• Bachelor's degree preferred in science or related field.
• Minimum 2 years of practical Quality experience in an FDA-regulated environment (503B, pharmaceutical, medical device, or related).
• Knowledge of cGMP guidelines and quality system requirements.
• Strong technical writing skills and ability to draft, edit, and review controlled documents.
• Excellent verbal and written communication skills.
• Strong attention to detail with proven organizational skills.
• Proficiency in Microsoft Office, Adobe, eQMS, and document/inventory management systems.
• Ability to work independently and collaboratively in a fast-paced, small-team environment.
• Strong time management skills with the ability to multitask and meet deadlines.

Responsibilities

• Issue Master Batch Records (MBRs).
• Assist with initial MBR review for accuracy and compliance.
• Issue and review production logbooks.
• Support Change Control processes.
• Scan, file, and maintain QA documents within SharePoint.
• Manage the Document Control Room for storage and retrieval.
• Assist with annual Iron Mountain archival projects.

Skills

Quality experience

cGMP knowledge

Technical writing

Communication

Attention to detail

Time management

Multitasking

Document control

Education

Bachelor's degree

Tools

Microsoft Office

Adobe

eQMS

Job description

PositionandScope

The Quality Assurance Technician is responsible for supporting Quality Assurance activities with a primary focus on Master Batch Record (MBR) issuance and review. This role also contributes to document control and compliance initiatives, helping ensure adherence to cGMP and FDA regulatory requirements. Strong technical writing, organizational skills, and attention to detail are essential. The QA Technician will play a key role in supporting Asteria Health’s mission of maintaining the highest quality standards in a 503B outsourcing facility.

EssentialDutiesandResponsibilities

• Perform issuance of Master Batch Records (MBRs).
• Assist with initial MBR review for accuracy and compliance.
• Assist with issuance and review of production logbooks.
• Support Change Control processes as needed.
• Scan, file, and maintain QA documents within SharePoint.
• Manage the Document Control Room to ensure proper storage, retrieval, and organization.
• Assist with annual Iron Mountain archival projects.

SkillsandExperienceRequired

• Bachelor’s degree preferred (science or related discipline).
• Minimum 2 years of practical Quality experience in an FDA-regulated environment (503B, pharmaceutical, medical device, or related industry preferred).
• Knowledge of cGMP guidelines and quality system requirements.
• Strong technical writing skills and ability to draft, edit, and review controlled documents.
• Excellent verbal and written communication skills.
• Strong attention to detail with proven organizational skills.
• Proficiency in Microsoft Office, Adobe, eQMS, and document/inventory management systems.
• Ability to work independently and collaboratively in a fast-paced, small-team environment.
• Strong time management skills with the ability to multitask and meet deadlines.

Shift: 1st shift - 7:00am to 3:00pm

Pay: $26/hr + DOE