Documentation Specialist I

Pyramid, Inc

Pearl River, NY

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JOB DETAILS

SALARY

$30–$33 Per Hour

JOB TYPE

Full-time

SKILLS

Biotech and Pharmaceutical, Coaching, 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, Team Player, Technical Writing, Time Management

LOCATION

Pearl River, NY

POSTED

1 day ago

Immediate need for a talented Documentation Specialist I. This is a 06+ months contract opportunity with long-term potential and is located in Pearl River, NY(Onsite). Please review the job description below and contact me ASAP if you are interested. 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 Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here. #Mor2

About the Company

Pyramid, Inc

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