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Quality Assurance Manager

Quality Assurance Supervisor/Manager ? Alachua, FL
Kelly Scientific is seeking a QA Supervisor or Manager for a biologic manufacturing company in the Gainesville, FL area. This is a direct hire opportunity. Monday-Friday on the 1st shift.
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The ideal candidate will have experience with CAPA?s and Investigations in a GMP setting. This role will report directly to the QA Director.
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Position Description/Summary:
This position oversees a team of Quality Operations Associates and Specialists responsible for daily support activities related to the manufacturing operation in Alachua, FL.? The supervisor supports regulatory compliance with FDA and European cGMPs, ICH, and industry standards, as well as compliance with corporate policies, standards and procedures.
The supervisor is responsible for coordinating with internal and external stakeholders to ensure exception reporting and continuous improvement initiatives are implemented in a timely manner or are otherwise communicated and appropriately assessed in the quality system, prior to product final disposition.
The supervisor is client facing and may be called upon to represent quality assurance in client meetings, audits, and updates.? The supervisor may also participate in the release of product batches and complete responses to client review of above documentation and release.
Essential Responsibilities:
Organize, plan, schedule, assign and follow through on the timely review and completion of controlled production records, test records, solution batch records, reagent preparation records, internal audits, environmental monitoring data review, stability data and audit report documentation performed by the QA Compliance department.
Lead and assist problem-solving and root-cause analysis sessions. Interfaces with Manufacturing, Engineering and Technical staff to develop and implement corrective actions and process improvements. Evaluate and work with Manufacturing, Quality Control, and Facilities to reduce preventable deviations through procedure creation, revision, or process mapping.
Support client audits and regulatory audits.
Oversees the quality inspection and AQL sampling of finished products.
Trains and mentors incoming quality staff, including overseeing new-employee on-boarding, development of existing training curriculum for quality operations and identifying training opportunities.? Assists in the identification of exceptional performers and elevates performance issues to the Quality Manager.
Normal work hours: 8:00 a.m. to 5 p.m. with occasional weekends. Additional hours may be required outside of the 40-hour work week depending on scheduled timelines and workload
Knowledge, Skill, and Requirements:
Bachelor?s degree with a minimum of three years of experience in a Quality Assurance group in a biopharmaceutical or pharmaceutical cGMP industrial environment or exempt by Manager?s approval.?
Supervisory experience a plus
Physical Demands:
While performing the duties of this job, the employee is frequently required to stand; sit; walk, use hands to operate computers, printers, scanners and reach with hands and arms; and talk and hear.
The employee must occasionally lift and/or move up to 10 pounds.? Specific vision abilities required by this job include close vision, and ability to adjust focus.?
In the performance of the duties of this job the employee is required to communicate in English using telephone and e-mail.
Indoor lighting of normal brightness. The noise level in the work environment is usually moderate.



Why Kelly??

With Kelly, you?ll have access to some of the world?s highest-regarded scientific organizations?
providing you with opportunities to work on today?s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help
advance. We work with 95 of the Fortune 100? companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career?connect with us today.



About
Kelly Services?

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook, LinkedIn and Twitter.


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


 

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