QA Specialist I: Aseptic & Compliance Advocate

Kindeva Drug Delivery; Missouri; On-site; USD 52,000 - 76,000; Full time

Job summary

Kindeva Drug Delivery is seeking a QA Specialist I to provide quality oversight and compliance support across operations including aseptic filling, inspection, and packaging. You will review documentation against cGMP, support investigations, and contribute to continuous improvement with cross-functional teams.

The role requires a bachelor's in a science field or equivalent experience, knowledge of cGMPs, strong written and verbal communication, and willingness to work weekends to meet business

Qualifications

• Bachelor's degree in science or 1 year experience in the Pharmaceutical industry.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Decision making related to incident investigations and CAPA.
• Team environment experience across interdepartmental teams.
• Effective written and oral communication skills.
• Certified Quality Auditor (CQA) certification preferred.

Responsibilities

• Review and evaluate manufacturing and testing documentation for compliance with SOPs and cGMP standards.
• Provide quality oversight during shop floor activities, inspection readiness, and in-process checks.
• Identify quality issues and contribute to root cause analysis and corrective actions.
• Collaborate with cross-functional teams to support process improvements.
• Collect, analyze, and report departmental data to identify trends.
• Assist in training and mentoring QA colleagues.
• Demonstrate proficiency in aseptic techniques in aseptic processing areas.
• Communicate issues identified during batch production or record reviews to management.
• Review and edit SOPs, logbooks, and batch records for regulatory alignment.
• Participate in internal GMP audits and support audits by customers/regulators.
• Assist in review/edit of SOPs / Master Batch Records.
• Perform ERP transactions as applicable.
• Willingness to work weekends and holidays as needed.
• Other tasks assigned by management requiring quality expertise.

Skills

cGMP knowledge

Written and verbal communication

Data analysis

Teamwork

Decision making

Quality mindset

Willingness to work weekends/holidays

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related science

Tools

ERP systems

Job description

Kindeva Drug Delivery is seeking a QA Specialist I to provide quality oversight and compliance support across operations including aseptic filling, inspection, and packaging. You will review documentation against cGMP, support investigations, and contribute to continuous improvement with cross-functional teams.

The role requires a bachelor's in a science field or equivalent experience, knowledge of cGMPs, strong written and verbal communication, and willingness to work weekends to meet business