Kindeva Drug Delivery
Production Coordinator
Join Kindeva Drug Delivery as a Production Coordinator. You will support manufacturing activities, review batch records, coach cGMP compliance, and ensure aseptic processing resources are available. Responsibilities
Perform GMP audits of cleaning rooms and aseptic processing areas. Review production documentation (batch records, logbooks) for effective SOP compliance. Coach colleagues in cGMP 21 CFR 210 & 211 and ALCOA cGMP guidelines. Compose or revise departmental SOPs as required. Report significant shift activities to Supervisor or Manager/TL. Suggest effective corrective and preventive actions. Assist Supervisor in confirming inventory of materials and sterile items in the aseptic processing area. Coordinate equipment maintenance and repairs with Tech Services and QC Lab for laboratory testing. Support Filling Supervisor on daily activities and receive information on activities; provide MQA support for any quality issues. Collect and reconcile controlled documents. Train personnel as required. Assist 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 in pharmaceutical or manufacturing environments. Communication: Effective written and oral communication skills required. Computer: Microsoft Applications, Compliance Wire, Trackwise, Inventory Control in D365. Reasoning: Demonstrated reading comprehension and writing proficiency at the level required for the role. Physical: Ability to stand upright for several consecutive hours; 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. 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. California residents should review our Notice for California Employees and Applicants before applying.
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Join Kindeva Drug Delivery as a Production Coordinator. You will support manufacturing activities, review batch records, coach cGMP compliance, and ensure aseptic processing resources are available. Responsibilities
Perform GMP audits of cleaning rooms and aseptic processing areas. Review production documentation (batch records, logbooks) for effective SOP compliance. Coach colleagues in cGMP 21 CFR 210 & 211 and ALCOA cGMP guidelines. Compose or revise departmental SOPs as required. Report significant shift activities to Supervisor or Manager/TL. Suggest effective corrective and preventive actions. Assist Supervisor in confirming inventory of materials and sterile items in the aseptic processing area. Coordinate equipment maintenance and repairs with Tech Services and QC Lab for laboratory testing. Support Filling Supervisor on daily activities and receive information on activities; provide MQA support for any quality issues. Collect and reconcile controlled documents. Train personnel as required. Assist 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 in pharmaceutical or manufacturing environments. Communication: Effective written and oral communication skills required. Computer: Microsoft Applications, Compliance Wire, Trackwise, Inventory Control in D365. Reasoning: Demonstrated reading comprehension and writing proficiency at the level required for the role. Physical: Ability to stand upright for several consecutive hours; 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. 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. California residents should review our Notice for California Employees and Applicants before applying.
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