Quality Assurance Associate (Entry-Level) - Part-Time

Astrix Inc.; Kalamazoo (MI); On-site; USD 26,000 - 28,000; Part time

Job summary

Astrix Inc. is seeking an Entry-Level Quality Assurance Associate to join the pharmaceutical manufacturing team on a part-time basis in Kalamazoo, MI.

This role targets recent graduates or those with up to 2 years in a GMP environment, focusing on ensuring products are manufactured, documented, and packaged in compliance with cGMP and FDA regulations. The position involves supporting quality systems and collaborating with Manufacturing, Packaging, and Quality Control to maintain GDP and GMP

Qualifications

• Strong attention to detail and organizational skills.
• Ability to read and follow Standard Operating Procedures (SOPs).
• Basic understanding of Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Strong written and verbal communication skills.
• Proficient with Microsoft Office (Word, Excel, Outlook).
• Ability to work independently and collaboratively in a team environment.
• Excellent time management and problem-solving abilities.

Responsibilities

• Perform in-process quality inspections during manufacturing and packaging operations.
• Review batch production records for completeness, accuracy, and compliance with cGMP requirements.
• Conduct line clearance inspections before production and packaging activities.
• Support product release activities by verifying documentation and production records.
• Assist with investigations involving deviations, non-conformances, and quality events.
• Ensure Good Documentation Practices (GDP) are followed throughout manufacturing operations.
• Perform routine walkthroughs of production areas to verify compliance with SOPs and GMP standards.
• Assist in maintaining controlled documents, SOPs, and quality records.
• Support internal audits and regulatory inspections by preparing documentation and records.
• Work closely with Manufacturing, Packaging, Warehouse, and Quality Control departments to resolve quality issues.

Skills

Attention to detail

SOPs literacy

cGMP & GDP basics

Communication skills

MS Office

Teamwork

Time management

Education

Life sciences degree (Biology, Chemistry, Pharmaceutical Sciences, Microbiology)

Job description

Astrix Inc. is seeking an Entry-Level Quality Assurance Associate to join the pharmaceutical manufacturing team on a part-time basis in Kalamazoo, MI.

This role targets recent graduates or those with up to 2 years in a GMP environment, focusing on ensuring products are manufactured, documented, and packaged in compliance with cGMP and FDA regulations. The position involves supporting quality systems and collaborating with Manufacturing, Packaging, and Quality Control to maintain GDP and GMP