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Manufacturing Associate

ALLTECH CONSULTING SVC INC

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.• 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 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:
  • High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
  • Associate’s Degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 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 ascientific or engineering disciplineand 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. #J-18808-Ljbffr ALLTECH CONSULTING SVC INC

Vacancy posted 2 days ago
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