Manufacturing Associate I
Insight Global
Job Description
Job Summary: Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). Responsibilities vary based on Manufacturing Associate level, but key responsibilities will include:
Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices
Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand why behind the regulation
Understands aseptic technique concepts
Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
Able to operate and maintain equipment
Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
Follows and executes Standard Operating Procedures (SOPs)
Revises and authors simple SOPs
Follows and executes Batch Records (BRs)
Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
Lead/Senior only: Responsible for on the floor operation oversight and monitoring overall performance of aseptic technique and process execution, ensuring compliance with standards. Responsible as floor oversight to identify unacceptable practices and has the authority to make spot corrections and provide feedback on process and procedure adherence to employees in the cleanroom.
Compensation, Benefits, Notes of Roles:
Fully onsite role
Must be able to wear appropriate clean room attire & PPE.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law
Holidays and shift work often required based on manufacturing schedule as determined by Management.
Manufacturing Associate I
HS diploma with minimum 2 years experience in cGMP, aseptic technique, understanding of SOPs, follow/execution of batch records OR
Bachelors/Associates Degree in Science related field with 0-2 years experience.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
Experience / Education
High School diploma and over 2 years of relevant experience or
Associates/Bachelors (science preferred) degree with 0-2 years of relevant or
equivalent experience null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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