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Manufacturing Associate

Summary:

Operates production equipment; responsible for manufacturing and assembly of clinical and commercial products. Responsible for preparing equipment and materials for production. Maintains and updates manufacturing material inventory. Follows blueprints, guidelines and/or diagrams to ensure product specifications and tolerance levels are met. Prepares, reviews, and completes cGMP documentation. Participates in process development efforts, investigations, deviations, and corrective actions to support expansion efforts while maintaining the highest cGMP compliance and inspection readiness. Works under general supervision.

Essential Duties:

  • Perform activities to manufacture transdermal products in a cGMP environment.
  • Execute qualification work per written protocols and instructions.
  • Maintain cGMP compliance of manufacturing area and related documentations.
  • Assist on investigations for deviation resolution.
  • Record manufacturing room conditions.
  • Participate in the creation and revision of manufacturing related documents.
  • Perform disposal/removal of hazardous waste.
  • Perform cleaning duties as it pertains to manufacturing process/equipment and facility.
  • Assure compliance with quality policies and procedure related to manufacturing process/equipment qualification.
  • Work with Quality Control, Facilities, and Quality Assurance to complete assignments.

Qualifications:

  • BS Chemistry, Biology, Engineering or related science
  • Minimum 2-4 years of experience in a cGMP pharmaceutical, biotech, or medical device industry
  • Excellent oral and written communication skills
  • Good computer skills
  • Good interpersonal skills and the ability to work well in a team environment
  • Must be able to perform in a fast-paced environment
  • Detail oriented
  • Ability to lift 25 pounds and stand for extended periods of time
  • Must be able to pass extensive back ground check
  • Position may require overtime, weekend and/or holiday work
  • Experience may be used as a substitute for degree

Job Type: Full-time

Required education: Bachelor's

Required experience:

  • cGMP pharmaceutical: 2 years
  • Manufacturing: 3 years
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