MASTER JOB TITLE: Manufacturing Quality Assurance Group leader



POSITION OBJECTIVE: Responsible to lead daily Quality Assurance/ Inspection/AQL operations ensuring all resources are available, personnel are assigned and the production plan is achieved. Group Leaders are the subject matter expert for their assigned area of' Quality Assurance and responsible to be the front-line leaders on the production floor.

REPORTS TO: Sr. Quality Manager

MANAGES: MQA Inspectors


Essential Job Functions/Responsibilities

·Performs routine Quality Assurance Specialist tasks under the guidelines of established SOP's and cGMP regulations

Act as the front-line lead for daily operations ensuring the AQL inspections are performed per schedule; performs AQL inspections as required

·Considered the subject matter expert for Quality processes in their assigned areas


Finishing AQL processes and recommends process improvements to quality management

·Accurately documents data and reviews batch records under cGMP guidelines

·Responsible for training MQA Inspectors in proper processes and techniques

·Responsible for monthly inspection evaluation program (cGMP walkthroughs)

·Responsible for oversight of the Visual Inspection Qualification Program (Defect Recognition program)

·Responsible for the oversight of the Quality Retain program

·Coaches, counsels assigned direct reports; complete or assist with performance reviews as required

·Review and maintain log books, production batch records, and associated documents to comply with regulatory requirements, cGMPs

·Responds to and resolves downtime issues (i.e. equipment issues and Inspection Events)

·Investigates AQL Events and failures, performs non-conformance investigations as needed

·Communicates routinely with management to review employee performance

·Assist to develop a department culture of employee engagement and accountability

·Ensure that safe work practices are employed in the performance of daily activities

·May perform other duties as assigned

Required Education & Experience

·Two or four year degree preferred; a High school diploma or equivalent combination of education and work-related experience can suffice

·Minimum 2 years cGMP environment, with 1 year aseptic manufacturing experience preferred

·Previous experience in a leadership role is preferred

Required Skills & Abilities:

·Excellent verbal and written communication, coaching and teamwork skills. Ability to lead teams to achieve results

·Detail-oriented and self-motivated

·Excellent hand-eye coordination and manual dexterity

·Ability to read, comprehend, write, and communicate effectively in English

·Ability to carry out detailed written or oral instructions

·Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.

·Mathematical skills to perform calculations and conversions as needed

·Hands on Leader who works well in team environment


Strong computer skills to include MS Outlook & Excel, PowerPoint

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