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 ascientific or engineering disciplineand 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.