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Base pay range
$28.00/hr - $28.35/hr
Payrate: $28.00 - $28.35/hr.
Summary:
This role performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves the operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
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
Education & Experience:- High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
- Associate’s degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 years related experience; coursework with biotechnology focuses highly desirable, OR
- Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in ascientific or engineering disciplineand some relevant work 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.
Pay Transparency: The typical base pay for this role across the U.S. is: $28.00 - $28.35/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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Research, Analyst, and Information TechnologyIndustries
Pharmaceutical Manufacturing
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