Production Assistant- Childrenâs GMP
Production Assistant- Childrenâs GMP
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Job Description
The Production Assistant will aid in the execution of production processes ensuring strict adherence to regulatory requirements. Production activities include manufacture of biological drug products formulation of buffers to support manufacturing campaigns and drafting and revising SOPs and master production records under guidance. The ideal candidate will have the ability to adapt to a dynamic environment and most importantly a strong sense of teamwork and collaboration.
Key Responsibilities
Follow and execute quality/production processes under supervision ensuring compliance with relevant regulatory requirements (e.g. FDA USDA).
Follow SOPs and/or process flows related to production/quality/TPQ/HAL for given task.
Regularly check production activities for cGMP compliance ensuring batch records are accurate and equipment logs are complete.
Support in internal audits help in investigating deviations and assist in implementing corrective actions.
Assist with documentation tasks related to compliance with quality and regulatory standards.
Contribute to continuous improvement efforts using documentation like release specifications and variances.
Minimum Education and/or Training:
High School Diploma or GED required.
Minimum Experience:
Some familiarity with (or a strong interest in learning) production/quality systems (e.g. cell processing biologics manufacturing).
Basic understanding or willingness to learn Good Manufacturing Practices (cGMP).
Basic computer literacy and ability to use electronic systems for documentation.
Skills/Attributes:
Strong attention to detail and record-keeping.
Ability to adapt in a dynamic environment.
Strong sense of teamwork reliability and collaboration.
What We Offer
Hands-on training in a regulated GMP environment within a mission-driven organization.
Opportunities for professional and career development in biological manufacturing and quality operations.
The chance to directly contribute to life-saving clinical trials taking place at St. Jude Childrens Research Hospital.
Compensation
In recognition of certain U.S. state and municipal pay transparency laws St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets experience and training licensure and certifications and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $24.00 - $42.00 per hour for the role of Production Assistant- Childrens GMP.Explore our exceptional benefits!
No Search Firms
St. Jude Childrens Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
Required Experience:
Director
Employment Type
Full-Time
