What are the responsibilities and job description for the Aseptic Specialist position at Kindeva Drug Delivery Careers?
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
The purpose of this role is to observe and identify Aseptic Processing Area compliance deficiencies while partnering with Aseptic Operations to continuously improve aseptic behaviors and techniques in the execution of production related activities. In the process of observing deficiencies, this individual will coach and provide constructive feedback to aseptic personnel and management. Specialists will collect and evaluate information gained through the oversight process to develop and implement improvements to interactively correct and prevent compliance concerns across the aseptic manufacturing processes.
Role Responsibilities
Bachelor’s degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)
#LI-onsite #LI-BM1
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The purpose of this role is to observe and identify Aseptic Processing Area compliance deficiencies while partnering with Aseptic Operations to continuously improve aseptic behaviors and techniques in the execution of production related activities. In the process of observing deficiencies, this individual will coach and provide constructive feedback to aseptic personnel and management. Specialists will collect and evaluate information gained through the oversight process to develop and implement improvements to interactively correct and prevent compliance concerns across the aseptic manufacturing processes.
Role Responsibilities
- Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite.
- Provide immediate feedback during routine observation to develop and improve colleague techniques & capabilities.
- Observe and identify opportunities related to aseptic processing microbiological science, microbiological control strategies, the environmental monitoring program and how each impact aseptic manufacturing processes.
- Implement projects to improve aseptic operations to support effective and compliant process operations.
- Evaluate aseptic processes during air flow visualization studies.
- Act as an active quality observation area lead while observing aseptic technique and operations during media fill simulations.
- Maintain and update proper documentation – SOPs, training records, batch records, check sheets, logbooks, etc.
- Act as an active member of investigational activities as it relates to environmental & behavioral compliance events.
- Aseptic qualifications are completed and maintained.
- Must be self-motivated, able to work independently and have a problem-solving mindset.
Bachelor’s degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)
#LI-onsite #LI-BM1
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
