Senior Director, Quality Assurance Specialist
Company: Yanna Bee Llc
Location: Chicopee
Posted on: January 16, 2023
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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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