Production Coordinator

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

Assist the Production management on the manufacturing activities. Responsible of providing real-time review of production documentation, coach colleagues in cGMP (21 CFR 210 & 211) and cGMP (ALCOA & ALCOA +). Ensure the necessary documentation, machine parts; component and support materials are available inside the aseptic processing area when required.

Role Responsibilities

• Performs GMP audits of the cleaning rooms and aseptic processing areas as required
• Performs real-time review of production documentation (batch records, logbooks, etc.) for compliance on effective SOP
• As needed, coach colleagues in cGMP (21 CFR 210 & 211) and cGMP (ALCOA & ALCOA +) when opportunities for improvement are found.
• Compose new or revise departmental SOPs as required
• Reports any significant shift activities to Supervisor or Manager/TL.
• Ability to suggest effective corrective/preventative action
• Assist Supervisor to confirm the necessary inventory on materials and sterile items used in the aseptic processing area are available
• Assist with adherence to the production schedule by ensuring that the necessary documentation, machine parts, component and support materials are available inside the APA when required
• Act as a resource for the site's continuous improvement culture by propose ideas to reduce human error deviations and manufacturing improvements based on Six Sigma / Lean Manufacturing principles, IMEx, and be a member of cross-functional team as needed
• Batch Record review; coordinate equipment maintenance and repairs with the Tech Services group ; coordinate with QC Lab for laboratory testing (as Required by the Production Supervisor); coordinate with Materials and Planning for scheduling of filling operations and ordering of materials
• Support Filling Supervisor on daily activities and receive information on activities; and MQA for any quality issues/concerns
• Support on data collection
• Perform document issuance and reconciliation (controlled documents)
• Train the personnel as require
• Assists the Supervisor with special projects and other duties as assigned by Management.

Basic Qualifications

• Education: High School Diploma or Associates Degree required. Bachelor's degree preferred.
• Experience: 1-3 years' work experience required and/or combination of education and experience. Pharmaceutical or manufacturing experience highly desirable.
• Language Skills: Effective written and oral communication skills required.
• Computer Skills: Microsoft Applications, Compliance Wire, Trackwise, Inventory Control in D365.
• Reasoning Ability: Demonstrated reading comprehension and writing proficiency at level that meets 'role' and/or 'test' requirements. Ability to effectively communicate within a diverse group resulting in desired outcomes.
• Physical Demands: Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties. Additional requirements are line and product specific.
• Work Environment: Use of eye protection, gloves and other PPE is required.
• Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times.

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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.

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