Quality Assurance Technician - US

Kindeva Drug Delivery; Missouri; On-site; USD 60,000 - 90,000; Full time

Job summary

Kindeva Drug Delivery is seeking a QA Technician to provide QA oversight across Operations, including equipment and material preparation, compounding, filling, inspection, and packaging in aseptic environments. The role supports readiness walkthroughs, line clearance, and in-process checks to ensure conformance to cGMPs and standards.

Ideal candidates will have a scientific degree and strong attention to detail, with the ability to work with cross-functional teams, participate in audits, and

Qualifications

• HS/GED not required if a degree is provided.
• Bachelor's degree in a scientific field is preferred.
• Strong attention to detail and organizational skills.
• Ability to follow instructions and procedures.

Responsibilities

• Reviews manufacturing related documentation to ensure processes adhere to SOPs and cGMPs.
• Perform inspection readiness walk-throughs, line clearance and in-process checks.
• Provide QA support for manufacturing and testing activities including deviation investigations and batch documentation review.
• Identify and address non-conformances in manufacturing operations.
• Collaborate with cross-functional teams to support continuous improvement and audits.

Skills

Attention to detail

Organizational skills

Written and verbal communication

Education

Bachelor's degree in a scientific field

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

QA Technician provides Quality oversight of Operations (equipment and material preparation, compounding, filling, inspection, and packaging activities) in both aseptic and controlled environments to ensure conformance to established specifications, procedures, cGMPs and regulations. The QA Technician performs readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities and engages with cross functional teams as needed to support continuous improvement activities, incident investigations and changes.

Role Responsibilities

• Reviews manufacturing related documentation to ensure processes adherance and compliance with approved SOP’s and cGMPs.
• Responsible for performing inspection readiness walk-throughs, line clearance and in-process checks in support of manufacturing activities
• Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review
• Proactively identify and address non-conformances in manufacturing operations
• Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
• Collects, reports and is responsible for departmental data.
• Alerts management promptly to any issues identified during batch production / record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
• Reviews SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
• Participates in internal GMP audits and supports customer and regulatory audits.
• Assists in training Quality Assurance colleagues.
• Has the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
• Performs ERP transactions, as applicable.
• Must be willing to work overtime and weekends as needed to support business initiatives.
• Other tasks assigned by management.

Basic Qualifications

• HS/GED. Bachelors degree in a scientific field and industry experience is preferred.
• The individual must have strong attention to detail and organizational skills.
• The individual must be able to follow instructions and procedures
• Basic knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Demonstrated decision making ability with emphasis on overall quality, site priorities, results and achievements.
• Works well in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have effective written and oral communication skills.

#WH

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.