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Job description
Job Summary
Provide Quality oversight to QC Metrology, Technology Transfer, and the laboratories (Chemistry and Microbiology) by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations.
Also provides support of the Empower network, laboratory network and standalone computer systems that support the laboratories. Coordinates installation and maintenance of standalone and networked computer hardware and software within the laboratories. Troubleshoots hardware and software problems and provides general user support as required.
Salary Range: $73,614 - $103,528
* Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
* Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities
Support the plant by overseeing the following systems, but not limited to:
Technology Transfer: process validation, cleaning validation, continuous process verification, process improvements, packaging development, thermal cycling
Chemistry: method validation, equipment qualification, metrology, stability program, raw material, component release, USP updates
Microbiology: filter validation, method validation
Work in partnership with all plant groups towards the goal of producing quality products by:
Reviewing/approving protocols, investigative studies, raw data and reports
Review/approve changes in production batch records and implementation of new batch records
Review/approve deviations, OOSs (out of specification), OOTs (out of trend), OOTs (out of tolerance) and change controls
Perform audit trail review of all analytical equipment used in the laboratories
Support computer systems that support the laboratories
Maintains administrator support for the Empower network specific to the site, exclusive of IT's responsibilities for system backup and support
Provide high level technical support for all users
Review operational systems for quality and compliance to standards and software upgrades
Audit network for compliance to cGMP regulations
Create and maintain documentation for all procedures and systems that support the laboratories
Perform other duties as assigned by Management.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.