USA-Documentation Specialist I (Manufacturing/Quality) 1st Shift
Mindlance
Pearl River, NY
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JOB DETAILS
SALARY
$31–$35 Per Hour
SKILLS
Coaching, Corrective and Preventative Action (CAPA) Systems, Detail Oriented, Documentation, Interpersonal Skills, Maintain Compliance, Manufacturing, Metrics, Regulatory Compliance, Regulatory Requirements, Team Player, Time Management
LOCATION
Pearl River, NY
POSTED
29 days ago
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. 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
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.