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 MakeThe Manufacturing Specialist is responsible for direct support of process improvement and compliance directives associated with the manufacturing activities at the KDD Lexington facility. Direct ownership of process deviation investigations, corrective/preventive action (CAPA), and change control. Manufacturing Batch Record and SOP revision and review.
Role Responsibilities:- Quality Systems: Deviation / CAPA / Change Control
- Collaborate effectively with Quality Assurance and technical subject matter experts from other support departments to ensure Manufacturing commitments are completed in a compliant manner.
- Ownership of Quality System work such as deviations, complaints, OOS, OOT, etc. Execute on-the-floor investigation triage and perform root cause analysis.
- Review process, product and equipment related validation and stability protocols and reports
- Technical review of Batch Records, SOPs, and manufacturing processes. Develop and implement process improvements
- Required to work with some supervision by senior staff and with other departmental or non-departmental personnel.
- Participates in Manufacturing Process Improvement Teams and leads continuous improvement initiatives on the manufacturing floor.
- Employing change management strategies to engage, communicate, train, and support Manufacturing Technician staff
- Other assigned responsibilities as established by Manager.
Basic Qualifications:
HS Diploma or equivalent. 3+ years GMP experience required. BS degree in Engineering, Business/Operations, or related discipline preferred.
Knowledge of GMP regulations and regulatory requirements in pharmaceutical manufacturing.
Ability to make sound decisions regarding compliance-related issues with moderate supervision.
Must have strong attention to detail.
Ability to manage multiple priorities and tasks in a dynamic environment.
Strong communication skills (written and verbal) and strong organizational skills.
High level of personal/departmental accountability and responsibility.
Experience with programs such as Access, Excel, ERP, Power BI, Power Apps and an electronic document management system.
Ability to work in a team environment and to work within that team to maximize efficiency and throughput.
Lean manufacturing, continuous improvement experience preferred.
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.
