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.
Lifting to 40 lbs., unassisted may be required at times.
Frequent standing and walking is required, as this role requires presence on the manufacturing floor.
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 cGMPs
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 SOPs, 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
Associates Degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 years related experience; coursework with biotechnology focus highly desirable, OR
Bachelors 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 (cGMPs). 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.
PHYSICAL DEMANDS :
Extended amount of time walking, standing, bending, reaching, pushing, and pulling.
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