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Senior Director, Quality Assurance Specialist

Company: Yanna Bee Llc
Location: Chicopee
Posted on: January 16, 2023

Job Description:

Senior Director/Director, Quality Assurance Specialist(Contract to Permanent FTE)PositionThe Quality Assurance Specialist ensures compliance with regulatory requirements and internal company procedures while facilitating the QA Department's daily activities with emphasis on current Good Manufacturing Practices (cGMPs). Responsible for reviewing quality data, batch records, analytical records, and for dispositioning of product in adherence to appropriate procedures and specifications. May also provide Quality support to site projects, cGMP systems, and new products.Key Responsibilities:Assesses compliance with cGMP regulations on difficult and complex technical issues.Perform batch record review, analytical record review, and product disposition, including preparation of Certificates of Analysis.Participate and assist with regulatory audits and agency inspections.Participate in or lead internal and customer audits and complete questionnaires and provide input for various health authorityMay schedule, lead, or participate in the quarterly Site Quality Management Review.Coordinate and complete associated activities with regards to customer complaints and inquiriesDraft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.Reviews, approves, and, in some cases, investigates non-conformances that could affect the quality of pharmaceuticals and medical devices.Drives continuous proactive improvement of site quality system. Performs gap assessments with quality systems and Standard Operating Procedures to ensure compliance.Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.Supports strategic site and segment projects and initiatives, including, New Product Introductions.This position is not a supervisory role. However, this role is expected to consult on Quality Assurance requirements to impact overall site quality performance.QualificationsEducation:Minimum requirements include an Associate's degree or two-year technical training or certification, preferably in a science related area, or equivalent Quality Assurance training and/or education.Experience and Skills:Required:A minimum of 2 years of experience and working knowledge in a cGMP/highly regulated manufacturing environment is required.Preferred:QA experience within cGMP API manufacturing is highly preferred.Proficiency with Microsoft Office software programs. Ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations is preferred.Possessing an understanding of Quality Systems Regulations, cGMP regulations, ICH Q7, and FDA requirements for active pharmaceutical ingredients or medical devices is preferred.Ability to lead multiple initiatives daily while being flexible and responsive to shifting priorities when needed is preferred.Ability to apply risk management philosophy to business processes, decisions, and data is preferred.Ability to influence and collaborate with cross-functional teams and multiple partners at all levels of the organization is preferred.Able to prevent and resolve conflicts effectively is preferred.Other:Occasionally required to climb or balance (stairs/ladders); stoop, kneel, crouch, or crawl; and smell.Specificvision abilities required by this job include close vision, color vision, distance vision and ability to adjust focusTypically will work a traditional schedule; however must be willingto work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.Must also be available to be on-call after hours and weekends as needed.Primary LocationBoston, MAby Jobble

Keywords: Yanna Bee Llc, Chicopee , Senior Director, Quality Assurance Specialist, Executive , Chicopee, Massachusetts

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