Artificial Intelligence (AI), Coaching, Consulting, Corrective and Preventative Action (CAPA) Systems, Detail Oriented, Documentation, Employee Benefits, High School Diploma, Interpersonal Skills, Maintain Compliance, Manufacturing, Metrics, Regulatory Compliance, Regulatory Requirements, Safety/Work Safety, Short Messaging Service (SMS), Team Player, Technical Writing, Time Management
Job Diva ID: 26-15911
Pay Range: $30 - $33/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities :- 1st Shift: 1st Shift: Track and review manufacturing batch records to ensure compliance with regulatory requirements.
- Follows up with Manufacturing Technicians to ensure corrections are completed in a timely manner. Maintain error tracking metrics to address and correct repeated violations of GDP.
- Coach shopfloor technicians on GDP as applicable
- Identify and escalate GDP issues that could affect the safety, efficacy and quality of drug substance.
- Review batch record structure and recommend simplifications to minimize errors – as applicable.
- Ensure batch record review cycle time. Participate in deviation investigations and CAPA creation – as applicable.
Key Requirements and Technology Experience:
- Must have skills: - Fully onsite, Free parking. Possibility of extension High School diploma 5 years AA Degree, 3 + years of experience bachelor’s degree, final batch review 1+ year of experience
- Experience; CAPA, Batch review, technical writing, knowing how use documentation systems, locate errors and change action requirements.
- Quality system, Tech writers, Capa, ERP, experience. Documenting systems or similar for tech writer • Pharma/ bio tech is required
- Manufacturing GDP experience
- Deviations
- Must be detail oriented and able to work quickly with a high degree of accuracy.
- Must possess sound interpersonal and information gathering skills, be able to work in a team environment and interact effectively with others.
- Years of Experience: 0 - 3 Years
Our client is a leading Biopharmaceutical Industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration
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