Hiring: Quality Assurance Specialist I Company: Kindeva Drug Delivery Location: St. Louis County, MO Job Posted Time: 2026-09-10 11:46:15 Employment Type: Contract / Remote Target Skills & Keywords : Change Management, Root Cause Analysis About the job Experience: •1 years experience in the Pharmaceutical or related industry Required Skills: •Review and evaluate manufacturing and testing documentation to ensure compliance with SOPs and cGMP requirements, applying professional judgment where needed. •Provide quality oversight and guidance during shop floor activities, inspection readiness, and in-process checks, including deviation and laboratory investigations, change management, SOP revisions, and batch documentation review. •Identify and escalate quality issues and contribute to root cause analysis and corrective actions to maintain compliance standards. •Partner cross-functionally with cross-functional teams to support process improvements and ensure adherence to regulatory requirements. •Collect, analyze, and report departmental data to identify trends and support continuous improvement initiatives. •Assist in training and mentoring QA colleagues, sharing best practices to strengthen team capability. •Has the ability to understand and demonstrate proficiency in aseptic techniques and behaviors required in aseptic processing areas. •Communicate issues identified during batch production or record reviews promptly to management, demonstrating accountability and ownership of quality standards. Qualifications: •Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 1 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. •Collects, researches, analyzes, and presents data information skillfully. •Certified Quality Auditor (CQA) Certification preferred. •Position requires vision acuity testing and onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis. •The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!