QA Specialist: Elevate Quality in GMP Manufacturing

SpectronRx; South Bend (IN); On-site; USD 52,000 - 75,000; Full time

Job summary

SpectronRx is seeking an experienced Quality Assurance Specialist to join our Indiana team. The role focuses on maintaining the highest quality standards across QA activities in a cGMP environment.

You will develop and implement QA policies, perform inspections, audits, and training, and collaborate with site and corporate QA to improve processes. Strong attention to detail and communication are essential.

Qualifications

• High school diploma or equivalent required.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and Adobe Acrobat.
• Excellent communication and organizational skills.
• Ability to train and be trained.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Previous experience in quality assurance or similar field.
• Working knowledge of quality assurance tools, methods, and concepts.
• Solid knowledge of regulatory standards.
• Thorough understanding of project management.
• Excellent organizational skills and attention to detail.

Responsibilities

• Prepare and implement quality assurance policies and procedures.
• Perform routine inspections and quality tests.
• Identify and resolve workflow and production issues.
• Ensure that standards and safety regulations are observed.
• Document QA activities and create audit reports.
• Assist in internal audits and training.
• Liaise with external inspectors and QA teams.
• Oversee metrology program at the site (qualifications/validations).
• Attend quality-related meetings and interface with Corporate QA on issues.

Skills

Attention to detail

Excellent communication

Organizational skills

Data collection and analysis

Ability to train and be trained

Time management

Oral comprehension

Written comprehension

Education

High school diploma or equivalent

Bachelor’s degree preferred

Tools

Microsoft Word/Excel/Outlook/PowerPoint

Adobe Acrobat

Job description

SpectronRx is seeking an experienced Quality Assurance Specialist to join our Indiana team. The role focuses on maintaining the highest quality standards across QA activities in a cGMP environment.

You will develop and implement QA policies, perform inspections, audits, and training, and collaborate with site and corporate QA to improve processes. Strong attention to detail and communication are essential.