Quality Assurance Specialist II

2 weeks ago


Maryland Heights, Missouri, United States Kindeva Drug Delivery Full time

Kindeva Drug Delivery

Kindeva is a prominent global contract developer and manufacturer (CDMO) specializing in delivery platform technologies such as Autoinjectors, Inhalation, and Transdermal/Intradermal Patch Technologies. Our mission is to collaborate with clients to enhance patient outcomes globally. Together, as One Team, we are committed to producing many more tomorrows.

ROLE SUMMARY

This position serves as an entry-level role within the Quality Assurance department. Following a comprehensive training program, the individual will adhere to established specifications, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and regulatory guidelines set forth by the FDA. Post-training, the individual will be equipped to conduct sampling and inspections independently. The role requires the ability to make prompt decisions during inspections and to identify situations that may necessitate halting production. The individual will provide assistance to the lead as required.

ROLE RESPONSIBILITIES

The responsibilities associated with this position include, but are not limited to:

• Execute the sampling process in accordance with procedures to meet product specifications and requirements.

• Review batch records and GMP documentation.

• Monitor processes, troubleshoot issues, and escalate concerns to management as necessary.

• Conduct line clearances.

• Relay shift information to the lead prior to the next shift's arrival.

• Adhere to GMP documentation practices in manufacturing and packaging batch records.

• Assist the lead as needed.

• Recognize product status such as Approved, Hold, Rejected, etc.

• Comprehend Good Manufacturing Practice regulations.

• Utilize ANSI sampling plans effectively.

• Perform other related duties as assigned.

BASIC QUALIFICATIONS

• High School Diploma or GED required.

• A Bachelor’s degree in a scientific field is preferred. Candidates may have less than one year of relevant QA or pharmaceutical industry experience. Strong attention to detail and organizational skills are essential. Effective interpersonal and communication skills are necessary, along with the ability to follow instructions, policies, and procedures.

Physical/Mental Requirements

• While performing the duties of this job, the employee may be exposed to working near moving mechanical parts. The noise level in the work environment is typically moderate.

• The employee may occasionally be required to stand, use hands to handle or feel, reach with hands and arms, climb or balance, walk, sit, and communicate. The employee must occasionally lift and/or move up to 25 pounds.

• Specific vision abilities required for this role include close vision, color vision, and the ability to adjust and focus. A score of 8 or better for near vision (14") with both eyes is required, 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, and normal color vision is required as per Ishihara screening.

Non-Standard Work Schedule/Travel or Environment Requirements

• This position necessitates regular onsite attendance; remote or telecommuting options are not available.

• The individual must manage multiple tasks across various functions and handle competing priorities, including site responsibilities, frequent communications, and attending meetings.

• The ability to work effectively under strict production, time, and performance deadlines is essential.

• Willingness to work beyond typical work hours, which may include weekends and holidays, is required.

Covid-19:

Ensuring the safety of our employees and communities is a top priority for Kindeva Drug Delivery. We encourage vaccination for all eligible individuals.

Equal Opportunity Employer:

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



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