Manufacturing Specialist Job at Kindeva Drug Delivery Company in Lexington

Posted Tuesday, August 26, 2025 at 4:00 AM

Manufacturing Specialist

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 : As a Manufacturing Specialist, you will provide critical support for process improvements and compliance initiatives within our Lexington manufacturing facility. You will be directly responsible for process deviation investigations, corrective and preventive actions (CAPA), and change control. By ensuring that Standard Operating Procedures (SOPs) and Manufacturing Batch Records are reviewed and revised in compliance with current Good Manufacturing Practice (cGMP) standards, you will help safeguard product quality and ensure regulatory compliance. Your contributions will directly impact operational efficiency, compliance, and the delivery of safe, effective pharmaceutical products to patients.

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

Other:

• 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.
• Employ change management strategies to engage, communicate, train, and support Manufacturing Technician staff

Other assigned responsibilities as established by Manager

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 Aps 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. .

Physical Requirements:

Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus to read and execute documentation. The employee is required to follow all cGMP and safety procedures, wear required safety equipment, and perform all work in a safe manner. Proper lifting techniques must be used, with awareness of hazards in the work environment. The role requires occasional lifting and/or moving of up to 20 pounds.

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!

Job Family D - Production Operations - Compliance Investigation