Manufacturing Quality Assurance Specialist II - 2nd Shift

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: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of controlled Current Good Manufacturing Practices (cGMP) documentation and manufacturing records, including any deviations or Out-of-Specification (OOS) results that may have occurred during lot production. Participates in the release of raw materials, intermediates, and final products.

Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities, and keeps management informed on quality issues.

Responsibilities:

• Supports on-shift manufacturing operations and activities, including but not limited to real-time auditing of production batch records, samplin,g and Acceptable Quality Levels (AQLs), and line clearances.
• Supports the development and maintenance of Quality Systems as appropriate.
• Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
• Advises senior management on findings and recommendations related to internal and external auditing.
• Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
• Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards. Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
• Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
• Reviews and approves cGMP documentation, including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
• Develops and maintains metrics and trending reports for Compliance-related activities.
  
  Job Details

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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.

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