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26 days old

QA Manager

Kelly Services
Winslow, ME 04901
**Job Title:** QA Manager

**Location:** Winslow, Maine



The Quality Assurance Manager provides daily compliance oversight and guidance to Quality Assurance and manufacturing personnel. Quality Assurance responsibilities include managing non-conformance investigations, change controls, validations, batch disposition, and qualification activities against regulatory guidelines and Elanco quality standards. The QA manager, working with the Senior Director of Quality, will aid in planning and managing long term site quality goals.


Functions:


+ Provide a daily presence in the manufacturing environment to provide compliance guidance and oversight for process teams including quality assurance, manufacturing supervisors/operations, engineering/maintenance and technical services.

+ Consistently provide leadership, feedback, and coaching to Quality Assurance colleagues through routine performance evaluations and responsibility oversight.

+ Actively contribute to process teams by providing compliance guidance and oversight and participating in manufacturing gembas and internal audits.

+ Oversee disposition of raw materials, semi-finished (antigen), and finished materials (vaccine).

+ Responsible for quality systems including; document control, batch record review and release, distribution quality oversight, sample management, etc.

+ Provides guidance to ensure compliance with Elanco quality systems and regulatory compliance

+ Drives continuous improvement of all quality systems and processes

+ Assist with or communicate directly through verbal and/or in writing with regulatory authorities, as required

+ Participates in and provide direct guidance during both internal and external audits and inspections

+ Assist partners with writing change controls, deviations, and performing investigations

+ Responsible for the oversight of site Quality Management systems.

+ Aid in preparing and managing annual operating and capital improvement budgets.

+ Provides monthly metrics for site Quality Lead Team and Global network metric review meetings.

+ Communicates product quality problems, recommends corrective action (s), and specifies follow-up procedures.

+ Leads and/or participates in both quality and partner continuous and capital projects


**Minimum Qualifications:**


+ Bachelors degree (science or engineering degree preferred)

+ Must have a minimum of 5 years of experience in Quality or Manufacturing role

+ Demonstrate strong oral, written, and interpersonal skills

+ Demonstrated ability to lead and work within a team

+ Demonstrated consistent decision making and ability to act according to a strategic plan

+ Root cause analysis and troubleshooting skills

+ Proficiency with applicable computer systems

+ Demonstrated attention to detail and ability to work within quality systems

+ Technical writing skills


**Additional Preferences:**


+ A minimum of 2 years of management experience

+ Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office

+ Knowledge of or experience in Lean, Six-Sigma or Operational Excellence

+ Experience working in a regulated aseptic manufacturing environment

+ Excellent communication, organization, and leadership skills

+ Strong interpersonal and team building skills; ability to lead and influence in a team environment


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-07 Expires: 2022-10-08

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QA Manager

Kelly Services
Winslow, ME 04901

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