Manufacturing Associate

Found in: Talent US C2 - 1 week ago

Severn, United States HireTalent Full time
Job Title: Manufacturing Associate
Location: Harmans, MD
Duration: 6 Months on W2 (Temp-to-Hire)

Shift: 7AM - 7PM : Rotating Schedule Every 2 Weeks 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.

POSITION SUMMARY:
The Manufacturing Associate : 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 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

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
  • Bachelor s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant 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.