Manufacturing Quality Assurance Specialist II - Lexington, KY, USA
2 days ago
Job description
Our Work MattersAt 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.
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.Reviews and approves product complaint investigations and assists with investigations.
Performs activities associated with various one-time or ongoing projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (Good Practice [GxP], 21 Code of Federal Regulations [CFR] Part 11, etc.).
Supports regulatory inspections and customer audits. Assists the Manager with daily and project activities as needed.Performs other duties as assigned.
Qualifications:
Bachelor's degree in a scientific discipline. At least 3 years of Pharmaceutical/Medical Device cGMP quality experience.
Knowledge of data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available [ALCOA+]) and compliance with 21 CFR Part 11 for electronic records.
Knowledge of High-Performance Liquid Chromatography (HPLC) principles and the ability to review data for accuracy and completeness.Knowledge of microbiological testing principles and the ability to review data for accuracy and completeness.
Ability to assess problems, to identify solutions, to plan and implement necessary changes.
Experience in quality systems auditing (internal and/or external) preferred.
Familiarity with electronic Quality Management System (QMS) platforms (e.g., TrackWise, MasterControl, etc.).
Experience in manufacturing aseptically filled, sterile products preferred.
Advanced knowledge of cGMP regulations and validation principles (e.g., FDA 21 CFR Part 820, International Organization for Standardization [ISO] 13485, etc.).
Ability to work well in a team-oriented environment.Well-developed communication and technical writing skills.
Qualified to work with controlled substances.
Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.
Physical Requirements:
Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus to read/understand/execute documentation as required by the position
Employees are required to follow all cGMP and safety procedures.
Employee is required to regularly use their hands in order to handle materials and supplies.
Employee is required to regularly use their hands in order to handle materials and supplies.
Employee is required to effectively use communication by both telephone and electronic means.
Employee is required to regularly stand and walk for extended periods of time.
The employee must wear all required safety equipment and safely perform assigned work.
Employees must use proper lifting techniques and be conscious of hazards around him/her.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 25 pounds.
# LI-Onsite
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