Manufacturing Specialist

Kindeva; Lexington (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

Kindeva in Lexington, KY is seeking a Manufacturing Specialist to support process improvement and compliance at the KDD Lexington facility. You will own deviation investigations, CAPA, change control, and review batch records and SOPs to drive manufacturing quality.

Collaborate with QA and technical SMEs, lead continuous improvement on the shop floor, and apply lean methods to enhance throughput. Strong GMP knowledge, detail orientation, and the ability to manage multiple priorities in a

Qualifications

• HS Diploma or equivalent; 3+ years GMP experience; BS degree preferred.
• Knowledge of GMP regulations and regulatory requirements in pharmaceutical manufacturing.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Strong attention to detail and ability to manage multiple priorities.
• Strong communication and organizational skills.
• Experience with Access, Excel, ERP, Power BI, Power Apps and electronic document management systems.
• Lean manufacturing / continuous improvement experience preferred.

Responsibilities

• Collaborate with Quality Assurance and technical SMEs to ensure Manufacturing commitments are completed in a compliant manner.
• Ownership of Quality System work such as deviations, complaints, OOS, OOT, etc.; 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.
• Work with supervision by senior staff and other departments.
• Participates in Manufacturing Process Improvement Teams and leads continuous improvement initiatives on the floor.
• Employ change management strategies to engage, train, and support Manufacturing Technician staff.
• Other assigned responsibilities as established by Manager.

Skills

GMP compliance

Deviation / CAPA handling

Change control

Batch records review

SOP revision

Cross-functional collaboration

Lean manufacturing

Education

HS Diploma or equivalent

Bachelor's degree in Engineering, Business/Operations, or related field

Tools

Access

Excel

ERP

Power BI

Power Apps

Electronic document management system

Job description

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 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 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.