Job Details:
Quality Supervisor 2nd Shift.
*Description:*
• The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts.
• Essential Functions:* • Responsible for scheduling and coordinating daily priorities for incoming raw material, in-process material, finished product and in-process packaging/labeling operations sampling and inspection activities. • Trains, supervises and evaluates the performance of QA inspectors, QA Specialist and QA Auditors to assure compliance with Standard Operating Procedures/cGMP. • Responsible for final product: Monitors all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs. • Assists management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required. • Handles Change Controls, Deviations and CAPAs through effective quality management tools. • Handles customer complaints to include retrieval of samples, performing applicable tests, preparation of reports and submission before due date. • Monitors and ensures that batch records are audited per manufacturing/packaging/shipping requirements,when required. • Conducts internal audits for compliance with SOP, cGMP & FDA requirements.
• Additional Responsibilities:* • Initiates, investigates and completes CAPA for all QA unplanned deviations under the guidance of QA Manager. • Writes, reviews and revises SOPs as directed by QA Manager/Director. • Plans, monitors and supervises cross training of all QA Inspectors. • Monitors absences and prepares Kronos, HR requistions/data change forms for all shift personnel, whenever required. • Reviews performance of all QA Inspectors in the shift as and when directed by HR
• Education:* • Bachelors Degree (BA/BS) Preferred degree in Chemistry, Biology or other related technical field - Required • Experience:*
• Supervisory experience in FDA regulated industry • Skills:* • To be a team leader and player who can successfully meet the organization's goals within a stipulated time frame.- Intermediate • Must be able to multitask and adapt to a rapidly changing environment.- Intermediate • Strong communication and writing skills.- Intermediate • Must be able to problem solve and make decisions with limited supervision.- Intermediate • Must be able to lead, coach and supervise the team with flexibility.- Intermediate • Microsoft Office; able to learn in-house computer systems and software.- Intermediate • Specialized Knowledge:* • Knowledge of cGMPs.
Please send your resume today.
chuck@libertyjobs.com
key words: pharmaceutical packaging, quality engineer, qa supervisor, qa engineer, quality assurance.