Job Description

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.

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.

• Other duties as assigned

Education & Experience:

• 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.

PHYSICAL DEMANDS:

• Extended amount of time walking, standing, bending, reaching, pushing, and pulling.

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