What are the responsibilities and job description for the Manufacturing Associate position at Kaztronix?
Manufacturing Associate I
SHIFT - 12PM - 12AM (2-2-3 ROTATION) - ONSITE POSITION
The Manufacturing Associate I performs 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 weekend work is required.
Key Responsibilities include but are not limited to:
" 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.
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 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 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.
SHIFT - 12PM - 12AM (2-2-3 ROTATION) - ONSITE POSITION
The Manufacturing Associate I performs 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 weekend work is required.
Key Responsibilities include but are not limited to:
" 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.
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 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 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.
