Location: 123 7555 Harmans Rd. Harmans 52-1667981 Harmans MD 21077 United States
Customer Account Managers: Hilton, Steve
Duration: 6 MONTHS.
Timings: 7AM – 7PM
100% Onsite Role
Note- SHIFT - 7AM - 7PM ROTATE SCHEDULE EVERY 2 WEEKS 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.
Description
POSITION SUMMARY
The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
Shift work and/or weekend work may be required at times.
Key Responsibilities
Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s
Performs the weighing, dispensing of raw materials for media and buffers
Performs the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.
Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
Dispensing, labeling, transfer/staging of raw materials and parts
Assembly/disassembly, cleaning and sterilization of components, parts, and equipment
Maintaining equipment, area, and cleaning logbooks
Cleaning sanitizing production rooms and equipment
Stocking production and cleaning supplies
May author/ review/improve SOP’s, batch records, protocols, and technical reports
Actively participates in training activities, managing their individual training plan.
Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
Other duties as assigned
Position Requirements
High School Diploma with a minimum of 2-4 years GMP Manufacturing experience
OR
Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable,
OR
Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience
Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
Must be team-oriented (proactively builds healthy working relationships between peers, their department, and other groups).
Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
Thanks & Regards,
Kalyan K | Technical Recruiter
Email: Kalyan@intellectt.com
Direct: +1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Seniority level
Associate
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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