KD
Senior Compliance Investigation Specialist
full-time•Bridgeton
About this role
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
- Education: The successful candidate will have a minimum of nine years of applicable experience and a 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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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.
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What you'll do
- The incumbent will manage Manufacturing Investigation Reports and Corrective and Preventive Actions within Sterile Product Manufacturing operations. They will also collaborate with management and Quality Assurance to ensure compliance and effectiveness of investigations.
About Kindeva Drug Delivery
Kindeva is a global powerhouse CDMO dedicated to manufacturing more tomorrows. Leveraging more than 100 years of innovation, Kindeva provides unrivaled expertise at every stage of pulmonary, nasal, injectable, intradermal, and transdermal therapy development and manufacturing. Whether providing holistic analytical support or scaling sterile injectable fill-finish operations, every solution is backed by extensive technological capabilities, deep regulatory knowledge, and state-of-the-art facilities across the U.S. and U.K. Kindeva’s proactive, informed solutions minimize risk and maximize confidence from ideation through commercialization, bringing high-quality products to patients in need, faster. For more information about our leading drug-device CDMO, please visit www.kindevadd.com.
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Frequently Asked Questions
What does a Senior Compliance Investigation Specialist do at Kindeva Drug Delivery?
As a Senior Compliance Investigation Specialist at Kindeva Drug Delivery, you will: the incumbent will manage Manufacturing Investigation Reports and Corrective and Preventive Actions within Sterile Product Manufacturing operations. They will also collaborate with management and Quality Assurance to ensure compliance and effectiveness of investigations..
Is the Senior Compliance Investigation Specialist position at Kindeva Drug Delivery remote?
The Senior Compliance Investigation Specialist position at Kindeva Drug Delivery is based in Bridgeton, Missouri, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the Senior Compliance Investigation Specialist position at Kindeva Drug Delivery?
You can apply for the Senior Compliance Investigation Specialist position at Kindeva Drug Deliverydirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.