QA Inspector II
8 months ago
Employment Information
Kindeva Drug Delivery
ROLE SUMMARY
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Ready to work with purpose? Look no further, we are hiring for a motivated, talented, and passionate QA Inspector II to join our St. Louis Missouri team!
The QA Inspector - Aseptic will be able to audit aseptic processes for conformance to established specifications, procedures, cGMPs, and FDA regulations and identify any non-conformances. This position requires excellent written and oral communication and the ability to work effectively across multiple departments to achieve initiatives. The incumbent must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors, and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.
ROLE RESPONSIBILITIES
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves. The employee will also be required to remain in the full body garb suit, hood, mask, goggles, and gloves for several hours at time. Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights, or a combination of both), weekends and/or holidays. Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary-, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
This is a full-time position in the production floor / Aseptic area.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
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.
ROLE SUMMARY
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Ready to work with purpose? Look no further, we are hiring for a motivated, talented, and passionate QA Inspector II to join our St. Louis Missouri team!
The QA Inspector - Aseptic will be able to audit aseptic processes for conformance to established specifications, procedures, cGMPs, and FDA regulations and identify any non-conformances. This position requires excellent written and oral communication and the ability to work effectively across multiple departments to achieve initiatives. The incumbent must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors, and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.
ROLE RESPONSIBILITIES
- Communicate non-conformances found during aseptic processing operations to the QA Manager / Supervisor on shift.
- Follow established procedures and identify gaps as written, update procedures as needed.
- Ensure adequate coverage for APA and Grade D/CNC areas throughout the shift.
- Lead monthly In Process Batch Record Review.
- QA Floor point of contact to QA and Production Management.
- Train Floor Quality Assurance colleagues.
- In-process review of production batch records for accuracy of documented entries and conformance to established procedures.
- Perform inspection readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities.
- Must be able to complete aseptic gowning qualification and work daily in a Grade A/B classified area.
- Understand and demonstrate aseptic techniques and behavior required in aseptic processing areas.
- Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues.
- Initiate event(s) in QTS per SOP-QLA-MQA-00720, as applicable.
- Perform PRISM transactions, as applicable.
- Must be willing to work overtime to support business initiatives.
- Weekend hours (Saturday and/or Sunday) are required.
- Performs other related duties as assigned.
- High School degree required; Bachelor's degree in a scientific discipline is preferred.
- The ideal candidate will possess a combination of relevant education, aseptic training and manufacturing/quality
- Minimum of 3 years of related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience is recommended.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves. The employee will also be required to remain in the full body garb suit, hood, mask, goggles, and gloves for several hours at time. Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights, or a combination of both), weekends and/or holidays. Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary-, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
This is a full-time position in the production floor / Aseptic area.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays, 3rd shift, and hours outside defined shift.
- Must be able to gown aseptically.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
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.
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