Integrated Quality Assurance Inspector

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 QA Specialist I, is responsible for Quality oversight of Operations (equipment and material preparation, compounding filling, inspection, and packaging activities) in both aseptic and controlled environments. The QA Specialist I, will provide site QA support activities (document review), and reviews / audits of product manufacturing and testing documentation, ensuring that products released meet regulatory and cGMP requirements. In support of site wide objectives, the QA Specialist I engages with cross functional teams as needed to support continuous improvement activities, incident investigations and changes.  ​

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, inspection readiness walk-throughs, line clearance, in-process checks, deviation and laboratory investigations, change management, SOP revisions and batch documentation review
• ​Proactively identify and address non-conformances in manufacturing operations and escalates to management as needed
• ​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.
• ​Assists in training Quality Assurance colleagues.
• ​Has the ability to understand and demonstrate aseptic techniques and behavior required in aseptic processing areas
• ​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 production / 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.
• ​Performs ERP transactions, as applicable
• ​Must be willing to work overtime, weekends and holidays as needed to support business initiatives
• ​Other tasks assigned by management

Basic Qualifications
• ​​​​Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 2 years experience in the Pharmaceutical or related industry
• ​The ideal candidate will possess a combination of relevant education, aseptic training and manufacturing/quality experience.
• ​Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• ​Demonstrated decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results and achievements
• ​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.​

This is a second shift position with hours 1:30pm- 10:30pm.
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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.

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