Job Description

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.


THE IMPACT YOU WILL MAKE


Integrated Quality Assurance Inspector (IQI) is responsible for Quality oversight of equipment and material preparation, as well as aseptic compounding, filling, and inspection activities. In support of site wide objectives, coordinates support activities, reviews, and audits semi-finished product manufacturing and testing documentation, ensuring that products released meet regulatory and cGMP requirements. The IQI engages with cross functional teams as needed to support continuous improvement activities, incident investigations and changes. Requires decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results, and achievements.


ROLE RESPONSIBILITIES

• Responsible for reviewing documents to ensure the manufacturing and testing processes adhered to the approved batch/testing record and are compliant with approved SOP's and cGMPs.
• 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
• Performs timely reviews and determines batch acceptability and product disposition.
• 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.
• Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.
• Alert management promptly to any issues identified during batch record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
• Review and edit 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 review and editing of SOPs / Master Batch Records.
• Other tasks assigned by management.

BASIC QUALIFICATIONS

• High school degree required
• More than 3 years of experience in the pharmaceutical industry.
• Experience in Batch Record Review/Audit/Disposition
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Independently consistently produces quality work.
• Works 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.
• Collects, researches, analyzes, and presents data information skillfully.
• Certified Quality Auditor (CQA) Certification preferred.

PREFERRED QUALIFICATIONS


Bachelor's degree in a scientific discipline is preferred.


PHYSICAL QUALIFICATIONS

• 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 occasionally include weekends and holidays.

The scheduled hours for this position are Monday through Friday 10:00am- 6:00pm and will eventually change to 2:00 pm- 10:30 pm.


#LI-onsite #LI-BM1


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


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!

Job Tags

Contract work, Temporary work, Local area, Remote work, Afternoon shift, Monday to Friday,

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