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 Senior QA Specialist provides strategic quality oversight and leads projects that enhance compliance and operational efficiency. This role manages investigations, change control, and product release while driving continuous improvement initiatives. The Senior QA Specialist collaborates across functions to influence quality systems and ensure alignment with regulatory requirements.
Role Responsibilities • Lead and approve complex document reviews to ensure manufacturing and testing processes comply with approved batch/testing records, SOPs, and cGMP standards. • Provide strategic QA oversight and guidance for manufacturing and testing activities, including shop floor support, inspection readiness walk-throughs, line clearance, in-process checks, deviation and laboratory investigations, change management, SOP revisions, and batch documentation review. • Independently identify, resolve, and influence corrective actions for non-conformances in manufacturing operations; drive systemic improvements to prevent recurrence. • Perform timely reviews and exercise judgment in determining batch acceptability and product disposition for high-impact decisions. • Operate effectively in a team environment and collaborate cross-functionally to lead quality initiatives, applying advanced judgment under short timelines while maintaining compliance and quality standards. • Collect, analyze, and interpret departmental data to identify trends and recommend improvements that enhance quality systems. • Lead training, mentoring and process improvement efforts for Quality Assurance colleagues to build organizational capability. • Demonstrate advanced proficiency in aseptic techniques and behaviors required in aseptic processing areas. • Apply deep knowledge of manufacturing operations and quality procedures to influence compliance strategies and process optimization. • Communicate issues identified during batch production or record reviews promptly to management, demonstrating accountability and ownership of quality outcomes. • Review and approve SOPs, Forms, Logbooks, and Master Batch Records for accuracy and regulatory alignment. • Participate in internal GMP audits and represent QA as a subject matter expert during customer and regulatory audits. • Support review and approval of SOPs and Master Batch Records to maintain compliance standards. • Perform ERP transactions as applicable to ensure accurate documentation and system integrity. • Must be willing to work weekends and holidays as needed to support business initiatives • Lead identification, management, and execution of projects associated with the Quality Unit to drive continuous improvement and compliance excellence. • Other tasks assigned by management requiring application of advanced professional judgment and leadership in quality systems.
Basic Qualifications • Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 5 years experience in the Pharmaceutical or related industry • Experience in Batch Record Review/Audit/Disposition • 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 • Demonstrated capability in project management • 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. PHYSICAL QUALIFICATIONS • 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. • It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position. • 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. #LI-onsite #LI-BM1
California residents should review our Notice for California Employees and Applicants before applying.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
