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Manager, Quality Systems

Job Description

Builds, develops and implements the Quality Systems, activities and resources including the following: Implementation of policies; standards and procedures to ensure finished products conform to regulatory standards; CMO selection and oversight; Auditing; Batch lot review; Deviation and CAPA Management; Document Control; Change Control and GMP Training.

Qualifications:

Bachelor’s Degree in a scientific or other related discipline.

Minimum of 5 years hands-on experience of analytical development and/or QC in a global pharmaceutical, biotechnology or medical device GMP environment or equivalent experience monitoring outside contractors.

Minimum of 3 years hands-on experience in Quality Assurance/Quality Control.

Extensive knowledge of GMP, ICH and FDA/EMA biologics regulations.

Excellent writer including but not limited to SOPs and reports.

Thrives in a dynamic work environment.

Ability to travel domestically and internationally up to 25% of the time.

Company

Nuron Biotech

Job Code

State or Province

Pennsylvania

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