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Manufacturing Associate I

Harmans, MD 21077

Posted: 02/21/2024 Employment Type: Contract Job Category: Scientific Job Number: 596966 Is job remote?: No Country: United States

Job Description


SHIFT - 7AM - 7PM ROTATE SCHEDULE EVERY 2 WEEKS 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.

POSITION SUMMARY

The Manufacturing Associate I perform 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/or weekend work may be required at times. KEY 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 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

POSITION REQUIREMENTS:
  • High School Diploma with a minimum of 2-4 years GMP Manufacturing experience

OR
  • Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 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 a minimum of 0-1 years relevant 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
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