QA Inspector II

Kindeva Drug Delivery

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!

ROLE SUMMARY

This is an entry level QA position. After training, the individual will perform to written specifications, SOPs, cGMPs, and FDA regulations. As part of the training, the person will have a working understanding of the benefits of quality and concepts behind the inspection process. After training, the person must be able to perform sampling and inspections without supervision. The person must have the ability/knowledge to make quick calls during inspection and can demonstrate the ability to recognize situations that may halt production. The individual will help the lead as needed.

ROLE RESPONSIBILITIES

• Role Responsibilities of this position include but are not limited to:
• Perform Sampling process as per procedures to full fill product specification and requirements.
• Review batch records/GMP documentation.
• Observe processes/trouble shoot issues and escalate to management as needed.
• Perform line clearances.
• Provide shift information to the lead before the next shift arrives.
• Follows GMP documentation practices in manufacturing and packaging batch records.
• Will assist the lead as necessary.
• Understands and recognizes product status such as Approved, Hold, Rejected, etc.
• Understands Good Manufacturing Practice regulations.
• Understands and utilizes ANSI sampling plans.
• Performs other related duties as assigned

BASIC QUALIFICATIONS
HS/GED. BS in a scientific filed is preferred. The individual may have less than one year of related QA or pharmaceutical industry experience. The individual must have strong attention to details and have organizational skills. The individual must have effective interpersonal and communication skills. The individual must be able to follow instruction, policies, and procedures.
Physical/Mental Requirements

• 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.
• Specific vision abilities required by this job include close vision, color vision, and the ability to adjust and focus. Must achieve a score of 8 or better for near vision (14") with both eyes, using the Titmus II vision tester or 20/25 on a near point Snellen acuity card at 16". Acceptable visual acuity is a Snellen fraction of 20/25 or greater. They must have normal color vision by Ishihara screening.

Non-Standard Work Schedule/Travel or Environment Requirements

• 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.
• 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.

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

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.