Senior Compliance Investigation Specialist II

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 incumbent will provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all Manufacturing Investigation Reports (MIR), Corrective and Preventive Actions (CAPA), evaluation of CAPA effectiveness and Operational Excellence (OPEX) projects within Sterile Product Manufacturing (SPM) operations. The incumbent will work with the SPM management team and Quality Assurance (QA) to facilitate the consistent, disciplined execution of the Event Report/Quality Assurance Report (ER/QAR) quality system ensuring the completeness and comprehension of the investigations and determination of most probable root cause. Finally, data gathering and metrics related the tasks above will be gathered, compiled and delivered to relevant requestors as required.

Role Responsibilities

• Completes and facilitates completion of Manufacturing Investigation efforts within SPM to ensure compliance with quality and cycle time standards.
• Provides guidance, coaching and feedback to all groups involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.
• Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations.
• Develops and recommends corrective and preventive actions to prevent/eliminate recurrent discrepancies and leads its implementation in manufacturing.
• Ensures that QAR system requirements M1/PHP are being executed as established in the site's Standard Operating Procedures (SOP) and other guidelines.
• Acts as the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs.
• Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation.
• Leads efforts to educate leaders and employees on OPEX methods, practices and tools.
• Leads process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility

Basic Qualifications

• The successful candidate will have a minimum of nine years of applicable experience
• Education: BA/BS/MS degree in Engineering, Chemistry, Physical/Biological Sciences, Business, Integrated Supply Management, or related applicable discipline that will enable the team to meet its mission.
• Effective team building skills
• Proven leadership and change management abilities
• Ability to effectively coach and mentor colleagues
• Strong oral and written communication skills
• Ability to influence at all levels of the site
• M1 and PHP education and experience
• Lean Six Sigma education and experience
• Ability to connect the mission of the team to site goals
• Green/Black belt certification is highly desired.
• Strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring is highly desirable.

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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.